Discover all the latest about our products, technology, and Target Health culture on our official blog.
June 29, 2020Target Healthy Eating
1 can (8 ounces) marzipan (more if you wish)
2 cups flour
2 teaspoons baking powder
1 pinch salt
1/2 cup canola oil
1 or 2 Tablespoons sugar
1 cup sour cream
12 ounces fresh strawberries, or frozen, or more (optional)
Powdered sugar for dusting, later (optional)
We've been so moved by the peaceful marching throughout American cities for over two weeks running, that we began to play the following music by one of our favorite African-American musicians.
You might find the film, The Human Stain (book by Philip Roth), as stimulating as we did, this weekend. Two great actors give memorable performances: Nicole Kidman and Anthony Hopkins
You can carry on, the torch of peace and brotherhood and simply live by the Golden Rule!
From Our Table to Yours
Have a Great Week Everyone!
June 29, 2020Regulatory
Adult-Onset Still's Disease (AOSD) is a rare and serious autoinflammatory disease of unknown origin. Autoinflammatory diseases are caused by abnormalities of the immune system, which trigger an inflammatory response that can damage the body's own tissues. Characteristics of AOSD have considerable overlap with Systemic Juvenile Idiopathic Arthritis (SJIA), which includes fever, arthritis, rash and elevated markers for inflammation. The overlapping features of AOSD and SJIA suggest this is a disease continuum rather than two separate diseases.
The FDA has approved Ilaris (canakinumab) injection for the treatment of Active Still's disease, including AOSD. Ilaris was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
The role of interleukin-1 (IL-1), a type of cytokine important in regulating the body's immune system, is well-established in AOSD and SJIA. Ilaris works by blocking the effects of IL-1 and suppressing inflammation in patients with this autoinflammatory disorder. The safety and efficacy of Ilaris for the treatment of patients with AOSD was established using comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with SJIA, as well as the safety of canakinumab in patients with AOSD and other diseases.
Common side effects reported by patients treated with Ilaris are infections (colds and upper respiratory tract infections), abdominal pain and injection-site reactions. The prescribing information for Ilaris includes a warning for potential increased risk of serious infections due to IL-1 blockade. Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with rheumatic conditions, in particular Still's disease, and should be aggressively treated. Treatment with immunosuppressants may increase the risk of malignancies. Patients are advised not to receive live vaccinations during treatment.
Ilaris was granted Priority Review designation, under which the FDA's goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
The approval of Ilaris was granted to Novartis Pharmaceuticals Corp.
June 29, 2020Virology
Neurons in the nose respond to inhaled odors and send this information to a region of the brain referred to as the olfactory bulb. Although the location of nasal neurons and their exposure to the outside environment make them an easy target for infection by airborne viruses, viral respiratory infections rarely make their way from the olfactory bulb to the rest of the brain, where they could cause potentially fatal encephalitis. According to a study published in Science Immunology (5 June 2020), a specific, front-line defense has been identified that limits the infection to the olfactory bulb and protects the neurons of the olfactory bulb from damage due to the infection.
Taking advantage of special viruses that can be tracked with fluorescent microscopy, the authors found that a viral infection that started in the nose was halted right before it could spread from the olfactory bulb to the rest of the central nervous system. Additional experiments showed that microglia, immune cells within the central nervous system, took on an underappreciated role of helping the immune system recognize the virus and did so in a way that limited the damage to neurons themselves. This sparing of neurons is critical, because unlike cells in most other tissues, most neuronal populations do not come back. Because of this, the central nervous system has evolved to include several defense mechanisms designed to keep pathogens out. However, when airborne viruses are inhaled, they travel through the nasal passages and interact with a tissue called the olfactory epithelium, which is responsible for our sense of smell. Neurons at the edge of the olfactory system extend small projections through the bone lining the nasal cavity. These projections enter the brain, giving it access to odors present in the air. Neurons in the olfactory epithelium also offer an easy way for viruses to bypass traditional central nervous system barriers by providing a direct a pathway to the brain.
For the study, the authors were able to show that CD8 T cells, which are part of the immune system responsible for controlling viruses, are very important in protecting the brain after infection of nasal tissue. Using advanced microscopy, the authors watched in real time how CD8 T cells protected the brain from a nasal virus infection. Interestingly, the CD8 T cells did not appear to interact directly with neurons, the predominately infected cell population. They instead engaged microglia, which are central nervous system immune cells that act a bit like garbage collectors by clearing cellular debris and dead cell material. When a viral infection occurs, the microglia appear to take up virus material from the surrounding environment and present it to the immune system as though they had become infected. In this way, infected olfactory neurons can hand off virus particles to microglia, which were then detected by the T cells. The T cells then respond by releasing antiviral molecules that clear the virus from neurons in a way that does not kill the cells. Because microglia are a renewable cell type, this type of interaction makes sense from an evolutionary standpoint.
Considerable attention has been paid to respiratory viral infections of late due to the current COVID-19 pandemic. The authors noted that, while that virus was not studied in these experiments, some of the symptoms it produces suggest that the same mechanism described here could be in play, since one of the interesting symptoms associated with infection by novel coronavirus is that many people lose their sense of smell and taste. The authors added that this suggests that the virus is not only a respiratory pathogen, but likely targets or disrupts olfactory sensory neurons as well.
For more information:
June 29, 2020Neurology
According to an article published online in Neurology (17 June 2020), combining more healthy lifestyle behaviors was associated with substantially lower risk for Alzheimer's disease. The study included data from nearly 3,000 research participants. Results showed that those participants who adhered to four or all of the five specified healthy behaviors were found to have a 60% lower risk of Alzheimer's. The behaviors were physical activity, not smoking, light-to-moderate alcohol consumption, a high-quality diet, and cognitive activities.
For the study, the authors reviewed data from two NIA-funded longitudinal study populations: The Chicago Health and Aging Project (CHAP) and the Memory and Aging Project (MAP). Study participants were selected from those studies who had data available on their diet, lifestyle factors, genetics, and clinical assessments for Alzheimer's disease. The resulting data pool included 1,845 participants from CHAP and 920 from MAP. The authors scored each participant based on five healthy lifestyle factors, all of which have important health benefits including:
1. At least 150 minutes per week of moderate- to vigorous-intensity physical activity - Physical activity is an important part of healthy aging.
2. Not smoking - Established research has confirmed that even in people 60 or older who have been smoking for decades, quitting will improve health.
3. Light-to-moderate alcohol consumption - Limiting use of alcohol may help cognitive health.
4. A high-quality, Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, which combines the Mediterranean diet and Dietary Approaches to Stop Hypertension (DASH) diet - The MIND diet focuses on plant-based foods linked to dementia prevention.
5. Engagement in late-life cognitive activities - Being intellectually engaged by keeping the mind active may benefit the brain.
The authors then compared the scores with outcomes of clinical diagnosis of Alzheimer's in the CHAP and MAP participants. Results showed that the risk of Alzheimer's was 37% lower in those with two to three, and 60% lower in those with four to five healthy lifestyle factors.
A 2017 research review and report commissioned by NIA concluded that evidence on lifestyle factors such as increasing physical activity, along with blood pressure management and cognitive training, is encouraging although inconclusive for preventing Alzheimer's. Since then, more research has emerged, such as the SPRINT MIND trial, which suggests intensive blood pressure control may slow age-related brain damage, and new trials have launched. For example:
1. The NIA-funded MIND Diet Intervention to Prevent Alzheimer's Disease is an interventional clinical trial comparing parallel groups with two different diets. An NIA-funded collaboration between Rush University and Harvard T.H. Chan School of Public Health and Brigham & Women's Hospital (grant number R01AG052583). MIND has enrolled more than 600 participants and is ongoing with an anticipated completion date in 2021.
2. The U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) is a multisite randomized clinical trial designed to evaluate whether lifestyle interventions ? including the MIND diet ? may protect cognitive function in older adults who are at increased risk for cognitive decline. NIA is funding the imaging, and neurovascular studies of POINTER.
June 29, 2020History of Medicine
Paul Berg (born June 30, 1926) is an American biochemist and professor emeritus at Stanford University. He was the recipient of the Nobel Prize in Chemistry in 1980, along with Walter Gilbert and Frederick Sanger. The award recognized their contributions to basic research involving nucleic acids.
Berg was born in Brooklyn, New York, the son of a Russian Jewish immigrant couple, Sarah Brodsky, a homemaker, and Harry Berg, a clothing manufacturer. Berg graduated from Abraham Lincoln High School in 1943, received his Bachelor of Science degree in biochemistry from Penn State University in 1948 and Ph.D. in biochemistry from Case Western Reserve University in 1952. Berg worked as a professor at Washington University School of Medicine and Stanford University School of Medicine, in addition to serving as the director of the Beckman Center for Molecular and Genetic Medicine. In addition to the Nobel Prize, Berg was presented with the National Medal of Science in 1983 and the National Library of Medicine Medal in 1986.
After completing his graduate studies, Berg spent two years (1952-1954) as a postdoctoral fellow with the American Cancer Society, working at the Institute of Cytophysiology in Copenhagen, Denmark and the Washington University School of Medicine, and spent additional time in 1954 as a Scholar in Cancer Research with the Department of Microbiology at the Washington University School of Medicine. He worked with Arthur Kornberg, while at Washington University. Berg was also tenured as a research fellow at Clare Hall, Cambridge. He was a professor at Washington University School of Medicine from 1955 until 1959. After 1959, Berg moved to Stanford University, where he taught biochemistry from 1959 until 2000 and served as director of the Beckman Center for Molecular and Genetic Medicine from 1985 until 2000. In 2000 he retired from his administrative and teaching posts, continuing to be active in research.
Berg's postgraduate studies involved the use of radioisotope tracers to study intermediary metabolism. This resulted in the understanding of how foodstuffs are converted to cellular materials, through the use of isotopic carbons or heavy nitrogen atoms. Berg's doctorate paper is now known as the conversion of formic acid, formaldehyde and methanol to fully reduced states of methyl groups in methionine. He was also one of the first to demonstrate that folic acid and B12 cofactors had roles in the processes mentioned.
Berg is arguably most famous for his pioneering work involving gene splicing of recombinant DNA. Berg was the first scientist to create a molecule containing DNA from two different species by inserting DNA from another species into a molecule. This gene-splicing technique was a fundamental step in the development of modern genetic engineering. After developing the technique, Berg used it for his studies of viral chromosomes.
Berg is currently a Professor Emeritus at Stanford and a member of the Board of Sponsors of The Bulletin of the Atomic Scientists. He was also an organizer of the Asilomar conference on recombinant DNA in 1975. The previous year, Berg and other scientists had called for a voluntary moratorium on certain recombinant DNA research until they could evaluate the risks. That influential conference did evaluate the potential hazards and set guidelines for biotechnology research. It can be seen as an early application of the precautionary principle.
Berg was awarded one-half of the 1980 Nobel Prize in Chemistry, with the other half being shared by Walter Gilbert and Frederick Sanger. Berg was recognized for his fundamental studies of the biochemistry of nucleic acids, with particular regard to recombinant DNA, while Sanger and Gilbert were honored for their contributions concerning the determination of base sequences in nucleic acids.
Other Awards and Honors
Berg was elected a Fellow of the American Academy of Arts and Sciences in 1966. In 1983, Ronald Reagan presented Berg with the National Medal of Science, and in 1989, he received the Golden Plate Award of the American Academy of Achievement. He was elected a Foreign Member of the Royal Society (ForMemRS) in 1992, and in 2005 he was awarded the Biotechnology Heritage Award by the Biotechnology Industry Organization (BIO) and the Chemical Heritage Foundation. In 2006 he received Wonderfest's Carl Sagan Prize for Science Popularization.
June 29, 2020Quiz
Viral 1) _____ are a fundamental tool in research. Production of viral vectors usually entail rendering an infectious virus to be replication incompetent or attenuated. This reduces the risks of working with these agents. Later generation viral vector systems are generally safer than early generation systems. Biomedical researchers are now busy finding ways to squash the new coronavirus. Meanwhile, synthetic biologists are busy 2) _____ it.
In February, a team from the University of Bern published a relatively simple recipe to artificially cook up SARS-CoV-2, the virus that causes Covid-19, in the lab. It required only two main ingredients: synthetic chunks of the virus's genomic instructions, which can be ordered online; and yeast. The manuscript was initially uploaded to the preprint server bioRXiv and now peer-reviewed and published in Nature. If further verified, it means that certified labs can clone whole samples of the coronavirus in a week at roughly $30,000. By democratizing access to the new virus, more labs can work on diagnostic tests, drugs, and vaccines, potentially saving millions of people faster than expected. Yet, in a nightmare scenario, the same technology that could rid us of the plague could also turn it into a 3) _____. These concerns often form the basis of conspiracy theories. But they are not pure fantasy. Back in 2014, federal scientists discovered half a dozen vials of smallpox virus, which most Americans born after 1972 do not have immunity against, while cleaning out storage facilities at the National Institutes of Health. Multiple influenza strains have been made more contagious using synthetic biology, based on testing in 4) _____. Although there has not yet been a synthetic viral Chernobyl, scientists are legitimately concerned about a lab-made or lab-leaked viral strain that could wreak havoc.
The Synthetic Virus Cookbook: To Beat a Virus, First know Your Foe.
The easiest way to get a hold of a virus is by obtaining infected biological tissue, which was difficult at the beginning of the pandemic. The second route is to try to grow the virus inside immortalized cells - in SARS-CoV-2's case, lung cells - but it's like manufacturing cars that blow up the factory and themselves halfway through construction. That leaves the third route: making the virus from scratch. Thanks to advances in synthetic biology and genome engineering, making entire virus genomes in bacteria or yeast hosts has become cheaper, easier, and faster. One recent paper for engineering SARS-CoV-2 used 5) _____ as the viral factory. However, the choice now may be the yeast route. The reason is that coronaviruses have extraordinarily large genomes, which makes it difficult for bacteria to cope with. Yeast, in contrast, is far more pliable. What is more, yeast also has a special power to automatically glue chunks of external 6) _____ material together into a full genome sequence. That is huge: rather than synthesizing the entire coronavirus genome through chemistry, it is possible to do it in chunks to reduce costs, and the yeast will magically assemble the pieces together like a puzzle. The project kicked off in January, soon after Chinese researchers released the virus's genomic blueprint. The team split the genome into 14 manageable chunks, each with slightly overlapping sequences, and ordered synthetic DNA that corresponded to those viral genome bits from a commercial company. Three weeks later, after receiving the fragments in the mail, the DNA, which together represent the entire SARS-CoV-2 genome, was inserted into yeast. Just two days later, the team was able to check the yeast, now blossomed into dot-like colonies on a plate, for signs of the virus's genome. Finally, the virus's genetic material was extracted from the yeast in DNA form and transformed it into RNA. This is like translating one language to another, which the virus naturally uses to multiply. In less than a week, the team was able to generate a fully synthetic virus, one relatively new to humans, and use it to infect sacrificial cells in a dish to study. As a proof-of-concept to the platform's power, the team also made a glow-in-the-dark version of the virus, which can help screen for anti-viral drugs. (If the drugs work, this rave version of the virus should lose its glow.)
The Biosafety Dilemma
Thiel's platform for engineering 7) _____ stands out in its speed and simplicity. Speed in an outbreak is essential, not just for containment but also for research. The new platform is a starting point for labs to easily change the coronavirus's genome, seeing what prevents it from replication or what genomic sequences make it weaker or even unable to infect humans. The beauty is that the system only requires the yeast to reassemble the virus's genome one single time. It is extremely easy to collect more coronavirus by reusing ready-made virus-producing yeast cells, like brewing 8) _____. Yet these selling points are exactly what worries bioethicists. The problem is that by publishing the technology roadmap, it is possible for both scientists and the bd guys to apply the same technique to synthesize more complex viruses, or develop a ?super virus' with high infectivity, virulence or vaccine-resistance.
Whether 9) ____ viruses will ultimately help quash the current 10) _____ is anyone's guess. However, the use of cloned deadly viruses is increasingly championed as a way to battle outbreaks, whether we are comfortable and ready or not.
ANSWERS: 1) vectors; 2) cloning; 3) bioweapon; 4) ferrets; 5) bacteria; 6) DNA; 7) SARS-CoV-2; 8) beer; 9) cloned; 10) pandemic
June 29, 2020What's New
Target Health is very pleased to announce that the CTTI registry trials project paper entitled Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative, has been published in Therapeutic Innovation & Regulatory Science Therapeutic Innovation & Regulatory Science, (2020; DOI 10.1007/s43441-020-00185-5). Our dear friend Steve Mikita, JD is senior author and Dr. Mitchel, CEO of Target Health is second author. Other esteemed authors are from Pfizer, FDA, Duke Clinical Research Institute, Celgene, CF Foundation, Medtronic and CTTI,
The journal provided this link https://rdcu.be/b46M7 to an Enhanced PDF notation tools, one-click supplements, citation file exports and article metrics. The article is also available as 'Online First': http://link.springer.com/article/10.1007/s43441-020-00185-5
Sharing Music During These Most Challenging Times
A suggestion to do around dinner time to deal with the pandemic, without any negotiations, each member at the breakfast, lunch or dinner table picks a piece of music and everyone listens. This week selections at our table were Wonderful World (Louis Armstrong), Una furtiva lagrima (A furtive tear) from the great and fun Italian opera L'elisir d'amore (Elixir of Love) by Gaetano Donizetti, and Paganini's Violin Concerto #1 performed by Ruggiero Ricci, a transformational exposure to classical music. Please share your solutions with friends and colleagues.
We know that this is a difficult time for all, including the planet at large. It is important that no matter what is going on, and as troubling as life seems now to be, every day, we must plant the seeds for future growth. If we all do, what we do well, together we will beat this. Each day find pleasure, whether with family/friends, doing a hobby, reading a book, playing Scrabble, taking a nap, watching a movie, cooking something special, making a date with your significant other, or whatever works for you and your families.
While there is a phrase better safe than sorry, we also want to add better smart than sorry. With COVID-19 literally still at our doorstep, remember that an ounce of prevention is worth a pound of cure. Also, now with the added protests in America, which is a tradition for change in our country, there is a lot on all of our shoulders. However, when all passes, we will adapt.
For more information about Target Health, contact Kathleen Kane Tremmel (firstname.lastname@example.org), Vice President, Business Development. For those who have been working with Warren Pearlson (email@example.com), Director, New Business Development, please continue to do so. For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Also visit the Target Health Eating Website to see all of the fantastic recipes since 2012.
Joyce Hays, Founder and Editor in Chief of On Target
Dr. Jules T. Mitchel, Editor
June 8, 2020Target Healthy Eating
2 or 3 scallions, chopped well
1 pound Chinese noodles, or your favorite spaghetti (not too thin)
2 teaspoons black sesame seeds, toast them first
2 Tablespoons sesame oil, plus extra
4 anchovy fillets ground in mortar & pestle with 4 garlic cloves - make a paste
3.5 Tablespoons low sodium soy sauce
1 or 2 shallots, well chopped
2 or 3 Tablespoons Chinese rice vinegar or other rice vinegar
2 or 3 Tablespoons rice wine or sake
2 Tablespoons Chinese sesame paste (tahini could substitute)
1 Tablespoon smooth peanut butter, or chunky or whatever you have
1 Tablespoon granulated sugar or 2 to 3 Tablespoons honey
1 Tablespoon finely grated fresh ginger
4 more fresh garlic cloves, chopped well
2 teaspoons chile-garlic paste, chile crisp, chile oil, or 2 pinches chili flakes (or more to your taste)
Half a peeled cucumber, seeded and cut into 1/8-inch by 1/8-inch by 2-inch sticks
1 cup chopped roasted peanuts (buy them roasted or roast them yourself)
Boil a large pot of water. Add noodles and cook about 5 minutes, until just a bit chewy Drain the noodles in a colander and rinse with cold water. Drain once again. Pat dry with paper towel. Add to the large bowl you'll serve them in and toss with a splash of sesame oil.
While noodles are boiling, toast your black sesame seeds and cook the scallions, shallots and grated garlic at the same time.
Take out a medium bowl (or food processor) to prepare the sauce: whisk or pulse together the remaining 2 Tablespoons sesame oil, and all the other ingredients: soy sauce, rice vinegar, sesame paste, rice wine, peanut butter, sugar, ginger, chopped garlic, garlic/anchovy paste, scallions, black sesame seeds, shallots.
Pour the sauce over the noodles and toss well. Garnish with cucumber and chopped peanuts.
This was an historic week for the U.S. It began with the darkness of death, of George Floyd and ended with the light of hope, the peaceful dedication and determination of nationwide protest marchers, encouraged by many great American military generals, and other kindred people from around the world.
Music perfectly describes my feelings, maybe your feelings were the same:
1) Beginning of the week
2) End of week
If music be the food of love, play on. - William Shakespeare
You can carry on, the torch of peace and brotherhood and simply live by the Golden Rule!
From Our Table to Yours
Have a Great Week Everyone!
June 8, 2020Regulatory
Alzheimer's disease is a progressive disease that typically begins with mild memory loss. It is one of the top 10 leading causes of death in the United States. According to the U.S. Centers for Disease Control and Prevention, in 2014, there were as many as 5 million Americans living with Alzheimer's disease. This number is projected to nearly triple to 14 million by 2060. Currently, Alzheimer's disease can only be definitively diagnosed by pathologic evaluation of a patient's brain once they have died (post-mortem). There are three imaging agents approved for post-mortem amyloid pathology with PET scans. Two proteins - tau and amyloid - are recognized as hallmarks of Alzheimer's disease. In patients with Alzheimer's disease, pathological forms of tau proteins develop inside neurons in the brain, creating neurofibrillary tangles.
The FDA approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help image a distinctive characteristic of Alzheimer's disease in the brain called tau pathology. Tauvid is a radioactive diagnostic agent for adult patients with cognitive impairment who are being evaluated for Alzheimer's disease. Tauvid is indicated for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs), a primary marker of Alzheimer's disease. After Tauvid is administered intravenously, it binds to sites in the brain associated with this tau protein misfolding. The brain can then be imaged with a PET scan to help identify the presence of tau pathology.
The safety and effectiveness of Tauvid imaging was evaluated in two clinical studies. In each study, five evaluators read and interpreted the Tauvid imaging. The evaluators were blinded to clinical information and interpreted the imaging as positive or negative. The first study enrolled 156 patients who were terminally ill and agreed to undergo Tauvid imaging and participate in a post-mortem brain donation program. In 64 of the patients who died within nine months of the Tauvid brain scan, evaluators' reading of the Tauvid scan was compared to post-mortem readings from independent pathologists who evaluated the density and distribution of NFTs in the same brain. The study showed evaluators reading the Tauvid images had a high probability of correctly evaluating patients with tau pathology and had an average-to-high probability of correctly evaluating patients without tau pathology.
The second study included the same patients with terminal illness as the first study, plus 18 additional patients with terminal illness, and 159 patients with cognitive impairment being evaluated for Alzheimer's disease (the indicated patient population). The study gauged how well Tauvid evaluators' readings agreed with each other's assessments of the readings. Perfect reader agreement would be 1, while no reader agreement would be 0. In this study, reader agreement was 0.87 across all 241 patients. In a separate subgroup analysis that included the 82 terminally ill patients diagnosed after death and the 159 patients with cognitive impairment, reader agreement was 0.90 for the patients in the indicated population and 0.82 in the terminally ill patients.
Tauvid's ability to detect tau pathology was assessed in patients with generally severe stages of dementia and may be lower in patients in earlier stages of cognitive decline than in the patients with terminal illness who were studied.
The most common adverse reactions in patients using Tauvid were headache, injection site pain and increased blood pressure.
Tauvid is not indicated for use in the evaluation of patients for chronic traumatic encephalopathy (CTE). The FDA granted the manufacturer of Tauvid Priority Review, under which the FDA's goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition. The FDA granted approval of Tauvid to Avid Radiopharmaceuticals, Inc.
June 8, 2020Oncology
According to a study published in Radiology (5 May 2020), whole body diffusion-weighted magnetic resonance imaging (DW MRI) may aid in the assessment of cancer treatment response in children and youth at much lower levels of radiation than current approaches.
The study compared DW MRI, which measures the density of tumors by tracking the movement of water molecules in tissue, to an established technique, fluorine 18 fluorodeoxyglucose positron emission tomography (FDG PET). FDG PET is typically used with computed tomography (CT) scans and measures tumor metabolism after an injection of radioactive glucose. Results showed that both techniques showed significant agreement in tracking tumor response to therapy, raising the possibility that DW MRI might one day be used in place of CT scanning, either together with FDG PET or alone, without the need to inject radioactive glucose. This new approach could reduce radiation exposure by 80% for combined FDG PET/DW MRI and fully eliminate radiation exposure for tumors that can be evaluated with DW MRI only.
For the study, 56 children and youth (ages 6 to 22 years old) completed 112 DW MRI and FDG PET scans. Participants had either lymphoma (cancer that begins in the lymphatic system) or sarcoma (cancer that starts in bone, muscles and other soft tissues). The authors simultaneously performed the two scans on the study participants before their treatment began and then after the first few weeks of chemotherapy. Evaluating the therapy response early allows clinicians to switch to a potentially more effective treatment if the tumor continues to grow. The authors found that the two methods yielded similar results, though in some patients FDG PET detected therapy response sooner than DW MRI. They concluded that more studies are needed to confirm their results in a larger number of patients and for different tumor types.
The authors explained that the study included only two tumor types because pediatric cancers are rare. They added, however, that they believe their study encompasses the largest number of PET/MRI scans obtained in a pediatric population to date.