Articles Posted in ‘Clinical trials’

Imaging Agent Development and Early Phase Clinical Trials

 PET scans of  lymph nodes with lymphoma in the groin and armpit (red areas).

NCI’s Cancer Imaging Program (CIP) is responsible for oversight and funding of oncology imaging research, such as the application of MRI (magnetic resonance imaging) and PET (positron emission tomography) in clinical trials. However, the larger goal of CIP is the development of new imaging techniques and their application to the development of new therapies for the cancer patient.
In phase 0 trials (for imaging agents) the goal is the development of assays that are verified in preclinical models that can be applied to first in-human studies to evaluate relevant biomarkers related to the target of interest. These studies, as would be expected, precede the established phase I through III trials that are required to establish safety and efficacy. These first in human studies are performed on a very small number of eligible trial participants. One of the underlying rationales for phase 0 studies of imaging agents is the intrinsic shortcomings of some animal models, specifically, the transferability of animal model data to humans.

New options and benefits regarding breast cancer treatment presented at ASCO

Sentinel lymph node biopsy. First of three panel illustration showing radioactive substance and/or blue dye is injected near the tumor, the injected material is followed visually or with a probe, and the first lymph nodes to take up the material are removed and checked for cancer cells.

Results from four separate clinical trials presented at ASCO this year should change clinical practice and could spare many women the side effects of some common cancer therapies.

Clinical Trial Design and the Future of Cancer Clinical Trials

Portrait of Dr. James Doroshow, Director, Division of Cancer Treatment and Diagnosis. Credit: NCI, Ernie Branson; Photographer

At the opening presidential session of the 2010 annual meeting of the American Society of Clinical Oncology in Chicago, NCI Director John E. Niederhuber, M .D., gave an introduction to James H. Doroshow, M.D., director of NCI’s Division of Cancer Treatment and Diagnosis. It was Dr. Niederhuber’s task to present the multiple achievements that Dr. Doroshow has brought to advancing clinical trial reform and development at NCI.