The American College of Radiology Imaging Network (ACRIN) Evaluation of Lung Cancer Treatment Response with positron emission tomography (PET) will be the first clinical trial supported by the Biomarker Consortium a public-private partnership whose membership includes the National Institutes of Health, the US Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS) as well as industry and patient advocacy groups. The Foundation of the National Institutes of Health (FNIH) will manage and coordinate the Biomarker Consortium. The purpose of this consortium is to promote the discovery, development, and qualification of biomarkers.

Its a great privilege for ACRIN to be associated with the Biomarker Consortium and to be entrusted with the conduct of its initial trial of PET scanning to evaluate response to treatment for lung cancer, said ACRIN Chair Bruce J. Hillman, MD, FACR. Imaging tests such as PET scanning can potentially reduce both suffering and cost for cancer patients by providing better selection of appropriate treatment and determining earlier after the start of therapy whether treatment will be effective.

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 Elias A. Zerhouni, MD, NIH director. The consortium enables government, industry, and philanthropy to come together to explore and develop common tools for a common purpose for everyones benefit.


The aim of the ACRIN trial is to demonstrate that PET can effectively and consistently measure quantitative changes in the uptake of the radiopharmaceutical agent FDG (fluorodeoxyglucose) during chemotherapy resulting in an early indication of the effectiveness of therapy in patients with advanced nonsmall-cell lung cancer.

The assessment of how tumors respond to chemotherapy plays an important role in clinical patient management as well as in drug development. Currently, therapy effectiveness is mainly evaluated by measuring tumor size by a CT scan and classifying tumor shrinkage according to standard criteria. However, tumor response rates evaluated in this manner do not correlate well with patient survival.

Also, response is not evaluated earlier than two to three months after the start of therapy which can result in many patients undergoing prolonged therapy without benefit. Several studies have suggested that FDG-PET may be used to monitor tumor response very early in the course of therapy, thus improving patient management by identifying the need to change the course of treatment for patients whose cancer is not shown to respond to their current therapy. The benefits include avoiding the side effects and costs of ineffective treatment.

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