Multi-site Validation and Application of a Consensus DSC-MRI Protocol

Status unconfirmed · Not applicable

Conditions studied: Glioblastoma Multiforme, Gliosarcoma

In brief

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.

Key facts

Study ID

NCT03401866

Run by

St. Joseph's Hospital and Medical Center, Phoenix

People needed

80

Starts

2018-02-01

Expected to finish

2021-07-01

Last updated by the study team

2018-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Does not meet inclusion criteria

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Brown University — Providence, Rhode Island, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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