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)
Change in rCBV within enhancing tumor — Baseline to 2 weeks Will determine whether binary changes (increase vs. decrease) in rCBV is associated with OS. Kaplan-Meier survival curves will be generated for both the increased and the decreased rCBV groups. The median survival time of both groups will be estimated and compared with a two-sided log rank test. Univariate Cox proportional hazards model will be used to test the association between changes in rCBV from baseline to 2 weeks and OS or PFS.
OS — Up to 5 years Will determine if binary changes (increase vs. decrease) in rCBV is associated with OS. The median survival time of both groups will be estimated and compared with a two-sided log rank test. Will determine whether changes in rCBV as a continuous variable within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with OS. Univariate Cox proportional hazards model will be used to test the association between changes in rCBV from baseline to 2 weeks and OS. The hazard ratio and its 95% confidence interval (CI) will be presented. Will determine the as
Trial sites (58)
Facility
City
Region
Status
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
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.
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