Summary
Redirect | ||||
---|---|---|---|---|
|
Excerpt |
---|
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 (Ktrans, 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. 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 4th case. The current protocol appears in Figure 1 below and can be found online (Protocol-ACRIN 6684 Amendment 7, 01.24.12) Figure 1. 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). Acknowledgements This shared data set was provided by Elizabeth R. Gerstner, MD, James R. Fink, MD, David A. Mankoff, MD, PhD, and A. Gregory Sorenson, MD, in collaboration with the American College of Radiology Imaging network (ACRIN) with recognition to Alexander M. Spence, MD founding Co-PI for ACRIN 6684 who has since passed. 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 UO1 CA080098, under the American Recovery and Reinvestment ACT of 2009 (ARRA) and UO1 CA079778. Please see QIN ECOG-ACRIN Data Sharing page for an overview and list of other ECOG-ACRIN data collections available on TCIA. 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 ProtocolAfter 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 4th 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. |
Acknowledgements
This shared data set was provided by Elizabeth R. Gerstner, MD, James R. Fink, MD, David A. Mankoff, MD, PhD, and A. Gregory Sorenson, MD, in collaboration with the American College of Radiology Core Lab with recognition to Alexander M. Spence, MD founding Co-PI for ACRIN 6684 who has since passed. Many thanks are due to the ACRIN 6684 trial team, and all the patients participating in the study. This study was supported by the American College of Radiology Imaging network (ACRIN), which received funding from the National Cancer Institute through: R01 CA082500, P30 CA016520, U10 CA180794, U01 CA190254, R50 CA211270 (Muzi); under the American Recovery and Reinvestment ACT of 2009 (ARRA) and UO1 CA079778; and through the NCTN Network Operations Group Awards U10 CA180820.
Please see QIN ECOG-ACRIN Data Sharing page for an overview and list of other ECOG-ACRIN data collections available on TCIA.
Localtab Group | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Localtab Group | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
...