ACRIN-FMISO-Brain

Summary

ACRIN 6684, a Multicenter, Phase II Assessment of Tumor Hypoxia in Glioblastoma Using 18F-Fluoromisonidazole (FMISO) With PET and MRI.

Main Objective: To determine the association of baseline FMISO PET uptake (tumor to blood ratio, hypoxic volume) and MRI parameters (K^trans, CBV) with overall survival, time to disease progression, and 6-month progression free  survival in participants with newly diagnosed glioblastoma (GBM).

Participants: A total of 50 participants will be enrolled.  A subset of 15 participants will have test-retest FMISO PET scans at baseline performed between 1 and 7 days apart (both scans completed prior to initiation of chemoradiation).  Each institution will not enroll more than 15 participants to this trial. 

Study Design Summary: In this study, 50 participants with residual GBM will undergo FMISO PET and MRI scans after surgery and prior to start of chemoradiation (baseline). 
The subset of 15 participants will have two FMISO PET scans within 1 to 7 days of each other to test reproducibility of FMISO PET; this substudy will continue to accrue until 15 participants have completed the two test-retest FMISO PET scans.  Participants will then resume standard of care imaging for GBM per treating physician discretion, which will be submitted to ACRIN.  Participants were followed to assess for disease progression and survivorship until the end of the study. 

Acknowledgements

This shared data set was provided by <<<Elizabeth R. Gerstner, MD others>>>> in collaboration with the American College of Radiology Imaging network (ACRIN). Many thanks are due to the ACRIN 6684 trial team, and all the patients participating in the study.

This study was supported by ACRIN, which received funding from the National Cancer Institute through <<<>>>, under the American Recovery and Reinvestment ACT of 2009 (ARRA) and UO1 <<<>>>.