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The objective of the ACRIN 6684 multi-center clinical trial was to determine the association of baseline FMISO PET uptake (maximal 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 multiforme (GBM). The trial also collected standard brain cancer data such as Karnofsky performance status, but also pathological biomarkers that included MGMT status, HIF1-alpha, GLUT1, CAIX, CD31, and alpha-SMA expression assays. 

There are two sets of volumes of interest (VOI) included with the ACRIN 6684 collection of MRI, PET and low-dose CT patient images.  These include delineation of enhancing brain tumor lesions and ¹⁸F-FMISO PET hypoxia maps.  More information about these masks can be found on the Detailed Description tab below.  Additional information about the trial is available in the Study Protocol and Case Report Forms. 

ACRIN 6684 Study Protocol

After establishing eligibility and enrollment to the study, baseline imaging of both MR and PET was performed within 2 weeks of starting therapy. FMISO, has been helpful in evaluating tumor oxygenation status, which may affect how well it responds to radiation and chemotherapy. The MRI scans were designed to measure tumor characteristics related to oxygenation status, including changes in blood flow, blood volume, and blood vessel size.

In the original protocol, following baseline imaging was an optional test-retest scan for FMISO PET only. Also included were PET and MRI scans at 3 weeks after the onset of chemo/radiation therapy, and 4 weeks following the end of standard treatment. Of the 50 patients enrolled in the study only one patient had a test-retest FMISO scan, and the requirement of scans mid and post therapy were dropped after the 4^th case.  The current protocol appears in the figure on the right, and can be found online ( Protocol-ACRIN 6684 Amendment 7, 01.24.12 ).  The latest protocol for ACRIN 6684 had PET and MR imaging performed only at baseline, up to 2 weeks prior to standard treatment (chemo + radiation therapy).  Mid and post-therapy scans were eliminated from the protocol after Case 4, and only one patient had a retest FMISO scan. Of the 50 enrolled patients, 42 patients had evaluable imaging data for the primary aims of the study (see Gerstner et al. 2016).

Note: The MRI DWI/DTI series acquired through GE or Siemens scanners for 30 patients have been stripped of their b-values and diffusion gradient matrix DICOM header fields making them unable to be processed for ADC map production. The patients scanned with Philips MRI scanners are intact.