Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials

Abstract

A recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss imaging endpoints for clinical trials in glioblastoma. This workshop developed a set of priorities and action items including the creation of a standardized MRI protocol for multicenter studies. The current document outlines consensus recommendations for a standardized Brain Tumor Imaging Protocol (BTIP), along with the scientific and practical justifications for these recommendations, resulting from a series of discussions between various experts involved in aspects of neuro-oncology neuroimaging for clinical trials. The minimum recommended sequences include: (i) parameter-matched precontrast and postcontrast inversion recovery-prepared, isotropic 3D T1-weighted gradient-recalled echo; (ii) axial 2D T2-weighted turbo spin-echo acquired after contrast injection and before postcontrast 3D T1-weighted images to control timing of images after contrast administration; (iii) precontrast, axial 2D T2-weighted fluid-attenuated inversion recovery; and (iv) precontrast, axial 2D, 3-directional diffusion-weighted images. Recommended ranges of sequence parameters are provided for both 1.5 T and 3 T MR systems.

Conventional and advanced magnetic resonance imaging in patients with high-grade glioma

“…Reproducible technical parameters and well-established imaging markers will allow for the incorporation of these approaches into future radiographic response assessment criteria necessary for optimization of clinical trials. Towards that goal standardized protocols for implementation in glioma treatment trials 100 and also for perfusion imaging 17 have been proposed and are being widely adopted.…”

Diffusion MRI Phenotypes Predict Overall Survival Benefit from Anti-VEGF Monotherapy in Recurrent Glioblastoma: Converging Evidence from Phase II Trials

“…However, one may argue this level of heterogeneity more accurately reflects the variability encountered in the real-world, implying diffusion MR may be a robust biomarker suitable for use in clinical practice. We posit a standardized protocol that includes identical T1-weighted pre- and post-contrast scans as well as standardized DWI acquisition, ideally in compliance with the recently outlined International Standardized Brain Tumor Imaging Protocol (45), would provide increased consistency and lower variability in T1 subtraction map-defined enhancing tumor volume and ADC estimation. Additionally, image distortions on diffusion MR images obtained using echo planar imaging may have led to inaccuracies when estimating the ADC characteristics within the contrast-enhancing lesion.…”

MRI Evaluation of Non-Necrotic T2-Hyperintense Foci in Pediatric Diffuse Intrinsic Pontine Glioma

“…16 Simultaneously, there is a growing need for using more robust, quantitative advanced MRI-based biomarkers which have more or less validated histopathological and/or pathophysiological interpretation and which take into account micro-environmental factors such as blood supply, oxygenation and metabolic activity, which are also known to influence drug delivery and therapeutic outcome. 17 …”