DSC-MRI in Measuring rCBV for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma
NCT ID: NCT03115333
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
146 participants
INTERVENTIONAL
2017-07-25
2027-05-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (DSC-MRI)
Patients undergo DSC-MRI within 3 days before bevacizumab initiation and at day 15.
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Undergo DSC-MRI
Interventions
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Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Undergo DSC-MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
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Principal Investigators
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Jerrold Boxerman
Role: PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Locations
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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
Countries
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Other Identifiers
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NCI-2016-01357
Identifier Type: REGISTRY
Identifier Source: secondary_id
EAF151
Identifier Type: OTHER
Identifier Source: secondary_id
EAF151
Identifier Type: OTHER
Identifier Source: secondary_id
EAF151
Identifier Type: -
Identifier Source: org_study_id