Multicenter, Phase II Assessment of Tumor Hypoxia
in Glioblastoma Using 18F-Fluoromisonidazole (FMISO) With PET and MRI
Protocol-ACRIN 6684 Amendment 7, 01.24.12 [PDF]
SOC-ACRIN 6684 Amendment 7, 01.24.12 [PDF]
Informed Consent-ACRIN 6684 [DOC]
Investigator's Brochure: FMISO, version February 2013 [PDF]
SOC-Investigator's Brochure: FMISO, version February 2013 [PDF]
Principal Investigator: Elizabeth R. Gerstner, MD
Main Objective: To determine the association of baseline FMISO PET uptake
(tumor to blood ratio, hypoxic volume) and MRI parameters (Ktrans, 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 will be followed to assess for disease progression
and survivorship until the end of the study.