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NCT03115333

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

Sponsor: ECOG-ACRIN Cancer Research Group

View on ClinicalTrials.gov

Summary

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.

Official title: Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

146

Start Date

2017-07-25

Completion Date

2027-05-07

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Gliosarcoma Recurrent Glioblastoma

Interventions

DIAGNOSTIC_TEST

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Undergo DSC-MRI

Inclusion Criteria: * 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)

Locations (58)

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

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

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

University of Missouri - Ellis Fischel

Columbia, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

East White Plains, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

University of Cincinnati/Barrett Cancer Center

Cincinnati, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Rhode Island Hospital

Providence, Rhode Island, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Memorial Hermann Texas Medical Center

Houston, Texas, United States

University Hospital

San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (58)