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Clinical Trials in Mexico / NCT03115333
Active, not recruiting Not applicable

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

NCT03115333 · tracked via the Priya Life Science Mexico tracker
Phase
Not applicable
Started
2017-07-25
Last updated
2026-09-15

Condition(s) studied

GliosarcomaRecurrent Glioblastoma

Investigational drug(s) / intervention(s)

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
Saint Joseph's Hospital and Medical Center Phoenix Arizona
Mayo Clinic Hospital Phoenix Arizona
Mayo Clinic in Arizona Scottsdale Arizona
Eden Hospital Medical Center Castro Valley California
Loma Linda University Medical Center Loma Linda California
USC / Norris Comprehensive Cancer Center Los Angeles California
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
VA Palo Alto Health Care System Palo Alto California
Boca Raton Regional Hospital Boca Raton Florida
Baptist MD Anderson Cancer Center Jacksonville Florida
Mayo Clinic in Florida Jacksonville Florida
Moffitt Cancer Center-International Plaza Tampa Florida
Moffitt Cancer Center - McKinley Campus Tampa Florida
Moffitt Cancer Center Tampa Florida
Emory University Hospital/Winship Cancer Institute Atlanta Georgia
Northside Hospital Atlanta Georgia
Northside Hospital-Forsyth Cumming Georgia
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
IU Health Methodist Hospital Indianapolis Indiana
Baptist Health Lexington Lexington Kentucky
Maryland Proton Treatment Center Baltimore Maryland
University of Maryland/Greenebaum Cancer Center Baltimore Maryland
Henry Ford Hospital Detroit Michigan
Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
Mayo Clinic Rochester Minnesota
Regions Hospital Saint Paul Minnesota
United Hospital Saint Paul Minnesota
Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters Missouri
University of Missouri - Ellis Fischel Columbia Missouri
Siteman Cancer Center at West County Hospital Creve Coeur Missouri
Washington University School of Medicine St Louis Missouri
Siteman Cancer Center-South County St Louis Missouri
Memorial Sloan Kettering Monmouth Middletown New Jersey
University of New Mexico Cancer Center Albuquerque New Mexico
Memorial Sloan Kettering Commack Commack New York
Memorial Sloan Kettering Westchester East White Plains New York
Memorial Sloan Kettering Cancer Center New York New York
UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina

+ 18 more sites — see the full list on the official registry below.

More ECOG-ACRIN Cancer Research Group trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03115333 on ClinicalTrials.gov ↗ ← All trials in Mexico