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This clinical trial is to validate and demonstrate the clinical usefulness of a protocol for Magnetic Resonance Imaging (MRI) in people with high grade glioma brain tumors.
Although DSC-MRI itself is not novel, the consensus protocol tested herein is newly developed in response to a stated need by federal agencies (FDA, NCI) for standardization of imaging endpoints, including perfusion-weighted MRI, in multi-center clinical trials of GBM therapies. Through use of stereotactic methodologies that have been used to demonstrate that rCBV(relative cerebral blood flow) and FTB(fractional tumor burden) measures made by the consensus DSC-MRI protocol are concordant with tissue histology, this multi-site trial will be the first to validate a consensus DSC-MRI protocol on multiple platforms representing all major MRI scanner manufacturers. The trial also formally compares two contrast agent dosing schemes proposed in the consensus protocol, a single-dose BTIP-compliant scheme and a double-dose scheme. Such a comparison has never been tested in patients before, and addresses a longstanding controversy regarding contrast agent administration and dosing for DSC-MRI. Successful validation of the consensus DSC-MRI protocol will likely shift clinical practice paradigms. To date, the widespread adoption of DSC-MRI has been limited by inconsistent published methodologies, rCBV thresholds, and impact on clinical decision making. This trial seeks to improve confidence in DSCMRI methodology as it will foster its adoption for multicenter trials, facilitating the development and testing of novel therapeutic agents and treatment strategies for GBM, and shift clinical practice paradigms by providing strong evidence to support the inclusion of DSC-MRI in established response assessment criteria (i.e., modified RANO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSC-MRI scan | Other | All subjects will receive a double dose injection protocol that will be split into multiple doses for sequential DSC-MRI scans. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSC-MRI | Diagnostic Test | The multiple dose protocol with sequential DSC-MRI scans enables comparison of BTIP compliant and double-dose injections schemes." |
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| Measure | Description | Time Frame |
|---|---|---|
| Histologic measures of tumor fraction | Apply fractional tumor burden (FTB) rCBV thresholding methods to quantify recurrent tumor burden and compare this against histopathologic tumor burden from corresponding surgical specimens. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the repeatability of rCBV measured with the consensus DSC-MRI protocol. | "The repeatability of rCBV measured with the consensus DSC-MRI protocol will be quantified using the intra-class correlation coefficient (ICC). | 1 week |
| Determine overall survival (OS) in recurrent GBM patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chad Quarles, PhD | Contact | 602-406-3484 | Chad.Quarles@barrowneuro.org |
| Name | Affiliation | Role |
|---|---|---|
| Chad Quarles, PhD | Barrow Neurological Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85054 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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follow up for up to 3 years post enrollment |
| 3 years |
| Brown University | Providence | Rhode Island | 02912 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |