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FDG-PET’s ability to monitor and foresee tumor treatment response and long-term outcomes will be put to the test in a new national study run by the American College of Radiology Imaging Network.
FDG-PET's ability to monitor and foresee tumor treatment response and long-term outcomes will be put to the test in a new national study run by the American College of Radiology Imaging Network.
Researchers opted to assess techniques in patients with advanced non-small cell lung cancer, because this is a common disease with a poor prognosis. Dr. Wolfgang Weber, an associate professor of molecular and medical pharmacology at the University of California, Los Angeles David Geffin School of Medicine, is lead investigator.
The trial is aimed at determining whether FDG uptake might be used as an early biomarker in the course of therapy to gauge if treatment is effective and should continue, potentially saving these patients from needless therapy. With a condition such as NSCLC, follow-up periods are shorter and it is easier to correlate metabolic changes in the course of chemotherapy with survival rates.
Currently, therapy effectiveness is evaluated mainly by measuring tumor size using a CT scan and classifying tumor shrinkage according to standard criteria. Tumor response rates evaluated in this manner, however, do not correlate well with patient survival.
In addition to determining whether FDG-PET helps assess treatment response, the trial results may have important implications for drug development. If PET is able to assess treatment response at earlier stages, it will be possible to assess new drugs more quickly. Clinical trials could therefore be shortened.
The PET study is the first clinical trial funded by the public-private partnership Biomarker Consortium, which includes the Pharmaceutical Research and Manufacturers of America, National Institutes of Health, FDA, Centers for Medicare and Medicaid Services, patient advocacy groups, and the philanthropic community. The consortium already has $1.1 million in funding and is dedicated to promoting development of biomarkers for a range of clinical purposes.
"The core challenge is to move medicine from a curative model of today to a preemptive era when we can identify and track a disease process as early as possible. The identification of biomarkers is an essential element for the new era of predictive, preemptive personalized medicine," said NIH director Dr. Elias A. Zerhouni.
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