13 August 2015 – The Jumpstarting Brain Tumor Drug Development Coalition (JBTDDC) today announced a new consensus protocol for magnetic resonance imaging (MRI) in brain tumor clinical trials to help better assess if a new treatment is effective. The coalition’s Brain Tumor Imaging Standardization Steering Committee published its recommended new standards for acquisition of imaging data in multicenter clinical trials, called the Brain Tumor Imaging Protocol (BTIP), in the advanced access online edition of the journal Neuro-Oncology.

The development and adoption of a standardized MRI protocol in brain tumor clinical trials will help validate and build confidence in the use of quantitative imaging surrogates as endpoints for drugs seeking FDA approval, including but not limited to the ‘Accelerated Approval’ pathway. In addition, a standardized protocol will incentivize brain tumor drug development by providing an accepted way to capture imaging information essential to the evaluation of future treatments.

“Malignant brain tumors, particularly glioblastomas, are some of the most complex and treatment-resistant cancers,” said Dr. Mark Gilbert, MD, chair of the Brain Tumor Imaging Standardization Steering Committee and chief of the Neuro-Oncology Branch of the National Cancer Institute. “Glioblastoma patients have a median survival of only 14-16 months, and fewer than 10 percent survive beyond five years of their diagnosis. With limited treatment options available, there is a critical need to quickly identify new, effective therapies for this patient population.”
As is the case across all oncology clinical trials, Overall Survival (OS) is the “gold standard” measurement of investigational brain tumor therapies’ effectiveness. However, OS trials are lengthy and expensive. Therefore, the field of neuro-oncology has a long-standing interest in using alternative endpoints that use imaging to measure tumor progression and response to determine the relative value of an investigational treatment.

Traditionally, response and progression are measured in neuro-oncology using MR imaging. However, there have been issues with variability in the interpretation of images and tumor measurements between observers and between treatment centers. The lack of standards in MR imaging acquisition protocols and differences in MR scanners (i.e. field strength, gradient system, manufacturer sequences) has limited the ability to combine imaging data across sites in a multicenter clinical trial study.

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