Despite extensive research, there has been only modest progress over the past two decades in developing more effective therapies for high-grade gliomas, the most common type of malignant primary brain tumor. Although there are many reasons for this limited progress, one important factor is the lack of reliable and widely accepted response assessment criteria and clinical trial endpoints. The Jumpstarting Brain Tumor Drug Development Coalition, consisting of the National Brain Tumor Society, Accelerate Brain Cancer Cure, the Society for Neuro-Oncology, and the Musella Foundation for Research and Information, are sponsoring workshops to evaluate and improve the use of various endpoints in brain tumor clinical trials, with a goal of accelerating the development of more effective treatments for brain tumors.
The first of these workshops was held in Bethesda, Maryland, on January 30, 2014. This workshop was conducted in close collaboration with the United States Food and Drug Administration (FDA), and included neuro-oncologists, neuro-radiologists, biostatisticians, radiation oncologists, neurosurgeons, representatives from industry and clinical research organizations, patient advocates, and representatives from the National Cancer Institute (NCI). This workshop focused on understanding the ability of neuroimaging to accurately assess treatment response in high-grade gliomas, and the value of current and emerging imaging-based endpoints in clinical trials. The goal was to reach consensus on optimal imaging endpoints and identify critical issues that the field needed to address to improve these endpoints. Ultimately, the aim was to improve clarity and speed, thus enhancing interest in pursuing clinical trials that can lead to FDA approval of novel therapies.
This supplement includes a summary of the presentations and discussions of the Jumpstarting Brain Tumor Drug Development Coalition imaging workshop and the proposals that emerged to further evaluate and improve the Response Assessment in Neuro-Oncology (RANO) criteria and standardize neuroimaging parameters. In addition, there are related reviews on 1) pros and cons of current brain tumor imaging, 2) emerging techniques and technologies in brain tumor imaging, 3) the impact of imaging measurements on response assessment in glioblastoma clinical trials, and 4) an imaging core lab perspective on glioblastoma imaging and response assessment in clinical trials (the latter is available online as part of the supplementary material).
We wish to thank all of the authors for their contributions to this supplement:
Lauren Abrey, Karla Ballman, Martin Bendszuz, Jan C. Buckner, Susan M. Chang, Timothy F. Cloughesy, Benjamin M. Ellingson, Howard A. Fine, Gregory V. Goldmacher, Michael D. Prados, Whitney B. Pope, David Raunig, David A. Reardon, A. Gregory Sorensen, Martin van den Bent, Patrick Y. Wen, W.K. Alfred Yung.
The list of workshop participants may be accessed here.
Supplementary Material
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