DSC-MRI in Measuring rCBV for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma

Running, not enrolling · Not applicable

Conditions studied: Gliosarcoma, Recurrent Glioblastoma

In brief

This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient?s response to treatment.

Key facts

Study ID

NCT03115333

Run by

ECOG-ACRIN Cancer Research Group

People needed

146

Starts

2017-07-25

Expected to finish

2027-05-07

Last updated by the study team

2026-07-17

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
• Patients will be eligible if the original histology was low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made (high-grade transformation)
• Karnofsky performance status >= 70
• Women must not be pregnant or breast-feeding
• Progression of disease assessed by local site using Revised Assessment in Neuro-Oncology (RANO) criteria, with plan to give whole-dose bevacizumab therapeutically, either as single therapy or in conjunction with other chemotherapeutic regimens; patients getting bevacizumab to support additional radiation therapy or immunotherapy, or primarily for reduction of edema rather than for tumor treatment, are excluded; this must be the patient?s initial recurrence
• Patient must not have been treated previously with immunotherapies (vaccines, checkpoint inhibitors, T-cells)
• 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
• Progressive enhancement (> 25% increase in contrast enhancing volume compared to nadir) on MRI within 14 days of registration, >= 42 days since completion of radiation/temozolomide therapy, and >= 28 days since surgical resection or cytotoxic chemotherapy; 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
• Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections
• Ability to withstand 22 gauge intravenous (IV) placement
• No history of untreatable claustrophobia
• No magnetic resonance (MR) incompatible implants/devices or metallic foreign bodies
• No contraindication to intravenous contrast administration
• Adequate organ function, including adequate renal function defined as estimated glomerular filtration rate (eGFR) >= 40 mL/min/1.73 m\^2 as calculated per institution standard of care, and meeting local site requirements for intravenous administration of gadolinium-based MRI contrast agents
• 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); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance
• Weight compatible with limits imposed by the MRI scanner table
• Patient must be scheduled to receive treatment with a standard dose regimen of bevacizumab (bevacizumab infusion on days 1 and 15 of a 28-day treatment cycle); patient can be treated with bevacizumab alone or in combination with other chemotherapies Exclusion Criteria: (see Inclusion Criteria)

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• VA Palo Alto Health Care System — Palo Alto, California, United States
• Boca Raton Regional Hospital — Boca Raton, Florida, United States
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Moffitt Cancer Center-International Plaza — Tampa, Florida, United States
• Moffitt Cancer Center - McKinley Campus — Tampa, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• Northside Hospital-Forsyth — Cumming, Georgia, United States
• Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• IU Health Methodist Hospital — Indianapolis, Indiana, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Maryland Proton Treatment Center — Baltimore, Maryland, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Minnesota Oncology Hematology PA-Maplewood — Maplewood, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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