DSC-MRI in Measuring rCBV for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma
- Conditions
- GliosarcomaRecurrent Glioblastoma
- Interventions
- Diagnostic Test: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
- Registration Number
- NCT03115333
- Lead Sponsor
- ECOG-ACRIN Cancer Research Group
- Brief 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.
- Detailed Description
PRIMARY OBJECTIVES:
I. To determine whether binary changes (increase versus \[vs.\] decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with overall survival (OS).
SECONDARY OBJECTIVES:
I. To determine whether the baseline pre-treatment rCBV measure alone is associated with OS.
II. To determine whether binary changes (increase vs. decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with progression-free survival (PFS).
III. To 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 or PFS.
IV. To determine the association between rCBV and OS when adjusting for the changes in enhancing tumor volume.
V. To determine whether baseline cerebral blood flow (CBF) or change in CBF is associated with OS or PFS.
OUTLINE:
Patients undergo DSC-MRI within 3 days before bevacizumab initiation and at day 15.
After completion of study intervention, patients are followed up every 3 months for 1 year and then every 6 months for up to 4 years.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 146
-
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
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Women must not be pregnant or breast-feeding
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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)
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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
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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
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Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections
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Ability to withstand 22 gauge intravenous (IV) placement
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No history of untreatable claustrophobia
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No magnetic resonance (MR) incompatible implants/devices or metallic foreign bodies
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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
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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
-
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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
(see Inclusion Criteria)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic (DSC-MRI) Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging Patients undergo DSC-MRI within 3 days before bevacizumab initiation and at day 15.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method PFS Up to 5 years Will determine whether binary changes (increase vs. decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with PFS. 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 PFS. Univariate Cox proportional hazards model will be used to test the association between changes in rCBV from baseline to 2 weeks and PFS. Kaplan-Meier survival curves will be generated for both the increased and the decreased rCBV grou
rCBV Baseline Will determine whether the baseline pre-treatment rCBV measure alone is associated with OS. Univariate Cox proportional hazards model will be used to test the association between baseline rCBV and OS. The hazard ratio and its 95% confidence interval will be presented.
CBF Baseline Will determine if baseline CBF is associated with OS or PFS. Kaplan-Meier survival curves will be generated for both the increased and the decreased CBF groups, for either OS or PFS. The median survival time/progression free 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 baseline CBF and OS or PFS. The hazard ratio and its 95% CI will be presented.
Change in CBF Baseline to 2 weeks Will determine if changes in CBF is associated with OS or PFS. Kaplan-Meier survival curves will be generated for both the increased and the decreased CBF groups, for either OS or PFS. The median survival time/progression free survival time of both groups will be estimated and compared with a two-sided log rank test. The hazard ratio and its 95% CI will be presented.
Related Research Topics
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Trial Locations
- Locations (58)
USC / Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Maryland Proton Treatment Center
🇺🇸Baltimore, Maryland, United States
UT Southwestern/Simmons Cancer Center-Dallas
🇺🇸Dallas, Texas, United States
IU Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Eden Hospital Medical Center
🇺🇸Castro Valley, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, 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
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Boca Raton Regional Hospital
🇺🇸Boca Raton, Florida, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, 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
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
University of Maryland/Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Minnesota Oncology Hematology PA-Maplewood
🇺🇸Maplewood, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
University of Missouri - Ellis Fischel
🇺🇸Columbia, Missouri, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
🇺🇸Woodbury, Minnesota, United States
Siteman Cancer Center at West County Hospital
🇺🇸Creve Coeur, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Siteman Cancer Center-South County
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan Kettering Monmouth
🇺🇸Middletown, New Jersey, United States
Siteman Cancer Center at Saint Peters Hospital
🇺🇸Saint Peters, Missouri, 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
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Carolinas Medical Center/Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
University of Cincinnati/Barrett Cancer Center
🇺🇸Cincinnati, Ohio, United States
Memorial Hermann Texas Medical Center
🇺🇸Houston, Texas, United States
Froedtert Menomonee Falls Hospital
🇺🇸Menomonee Falls, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
🇺🇸Oconomowoc, Wisconsin, United States
ProHealth D N Greenwald Center
🇺🇸Mukwonago, 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
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University Hospital
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Saint Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, 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
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States