Status:
UNKNOWN
Multi-site Validation and Application of a Consensus DSC-MRI Protocol
Lead Sponsor:
St. Joseph's Hospital and Medical Center, Phoenix
Conditions:
Glioblastoma Multiforme
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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, incl...
Eligibility Criteria
Inclusion
- Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery
- Patient is currently being treated with standard first-line therapy for glioblastoma/gliosarcoma
- Karnofsky performance status ≥ 70
- Age ≥ 18 years
- Women must not be pregnant or breast-feeding as gadolinium enhanced MRI is contra-indicated
- Progressive contrast enhancement (\> 25% increase in contrast enhancing volume compared to nadir, not corresponding to a region of peri-operative infarct seen on immediate post-op MRI) identified on routine surveillance MRI, with plan for surgical biopsy/resection. Measurable enhancement is defined as two perpendicular in-plane diameters of at least 10 mm and at least 10 mm in the 3rd orthogonal direction. This must be the patient's initial recurrence.
- Intratumoral hemorrhage (acute, subacute, or chronic) as seen on hemosiderin-sensitive (gradient-echo) MRI may preclude patient inclusion because of anticipated limited evaluation due to magnetic susceptibility artifact on the heavily T2\*-weighted DSC-MRI images. If the region of enhancing tumor not affected by blooming artifact on the hemosiderin-sensitive images does not meet the 10 x 10 x 10 mm "measurable enhancement" threshold specified elsewhere, the patient is ineligible.
- Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections
- No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR);
- Weight compatible with limits imposed by the MRI scanner table.
Exclusion
- Does not meet inclusion criteria
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03401866
Start Date
February 1 2018
End Date
July 1 2021
Last Update
January 17 2018
Active Locations (3)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85054
2
Brown University
Providence, Rhode Island, United States, 02912
3
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226