“It is well known that even minor differences in hardware or sequence timing may result in significant changes in image contrast,” said Dr. Benjamin Ellingson, PhD, of the Department of Radiological Sciences at the David Geffin School of Medicine at UCLA and lead author of the BTIP paper. “Moreover, a variety of MR protocols are commonly used for the same purpose, further hindering interpretation of imaging results from different treatment centers in the absence of tight control and standardization of image acquisition parameters.”

A meeting was convened by the JBTDDC in 2014 with the U.S. Food and Drug Administration, National Cancer Institute, clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trial cooperative groups, and patient advocacy groups to improve the accuracy of determining true response to a particular therapy and minimize errors in brain tumor clinical trials.


“During our participation in the Brain Tumor Endpoints Workshop, we identified standardization of imaging data acquisition and analysis as a step towards increasing the reliability of radiographic endpoints in brain tumor clinical trials, and improving the ability to assess the impact of therapies in neuro-oncology,” said Dr. Richard Pazdur, MD, director of the FDA’s Office of Hematology and Oncology Products.

As a leading advocate within the JBTDDC, the National Brain Tumor Society formed the Brain Tumor Imaging Steering Committee, chaired by Dr. Gilbert, and made up of key world-class leaders involved in aspects of neuro-oncology and neuroimaging for clinical trials across the US and Europe. The Steering Committee’s mission was to create the new, consensus protocol announced today.

The Brain Tumor Imaging Steering Committee published the new BTIP with scientific and practical justifications for the recommendations. The protocol is designed to minimize patient burden and has taken into account the different capabilities of imaging instruments across international medical centers. In addition, it incorporates new features that allow for potential enhancements in the analysis of tumor imaging data.

The paper outlining the protocol can be found here. For radiologists, imaging experts, scientists, and clinicians involved in neuro-oncology clinical research across academia and industry seeking to learn more about the new BTIP, a webinar featuring experts from the Brain Tumor Imaging Steering Committee is scheduled for Tuesday, September 22nd at 11:00am EST. For more information on the webinar visit here.

More HCB News