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Active, not recruitingNCT03115333Updated Sep 15, 2026

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

An interventional study of Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging in Gliosarcoma and Recurrent Glioblastoma, sponsored by ECOG-ACRIN Cancer Research Group. Active, not recruiting at 58 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by ECOG-ACRIN Cancer Research Group · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Gliosarcoma
  • Recurrent Glioblastoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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)
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
146 participants (actual)

Study arms

  • Experimental
    Diagnostic (DSC-MRI)

    Patients undergo DSC-MRI within 3 days before bevacizumab initiation and at day 15.

    Diagnostic Test: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Interventions

  • Diagnostic testDynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

    Undergo DSC-MRI

    Also known as: DSC-MRI, Dynamic Susceptibility Contrast-Enhanced MRI, DYNAMIC SUSCEPTIBILITY-CONTRAST MRI

05

What researchers measure

Primary outcomes

  1. Change in rCBV within enhancing tumor

    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.

    Time frame: Baseline to 2 weeks

  2. OS

    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

    Time frame: Up to 5 years

Secondary outcomes

  1. CBF

    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.

    Time frame: Baseline

  2. Change in CBF

    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.

    Time frame: Baseline to 2 weeks

  3. PFS

    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

    Time frame: Up to 5 years

  4. rCBV

    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.

    Time frame: Baseline

06

Study locations

58 sites
  • Saint Joseph's Hospital and Medical Center
    Phoenix, Arizona 85013, United States
  • Mayo Clinic Hospital
    Phoenix, Arizona 85054, United States
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • Eden Hospital Medical Center
    Castro Valley, California 94546, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • VA Palo Alto Health Care System
    Palo Alto, California 94304, United States
  • Boca Raton Regional Hospital
    Boca Raton, Florida 33486, United States
  • Baptist MD Anderson Cancer Center
    Jacksonville, Florida 32207, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
  • Moffitt Cancer Center-International Plaza
    Tampa, Florida 33607, United States
  • Moffitt Cancer Center - McKinley Campus
    Tampa, Florida 33612, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Emory University Hospital/Winship Cancer Institute
    Atlanta, Georgia 30322, United States
  • Northside Hospital
    Atlanta, Georgia 30342, United States
  • Northside Hospital-Forsyth
    Cumming, Georgia 30041, United States
  • Indiana University/Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana 46202, United States
  • IU Health Methodist Hospital
    Indianapolis, Indiana 46202, United States
  • Baptist Health Lexington
    Lexington, Kentucky 40503, United States
  • Maryland Proton Treatment Center
    Baltimore, Maryland 21201, United States
  • University of Maryland/Greenebaum Cancer Center
    Baltimore, Maryland 21201, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Minnesota Oncology Hematology PA-Maplewood
    Maplewood, Minnesota 55109, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Regions Hospital
    Saint Paul, Minnesota 55101, United States
  • United Hospital
    Saint Paul, Minnesota 55102, United States
  • Minnesota Oncology Hematology PA-Woodbury
    Woodbury, Minnesota 55125, United States
  • Siteman Cancer Center at Saint Peters Hospital
    City of Saint Peters, Missouri 63376, United States
  • University of Missouri - Ellis Fischel
    Columbia, Missouri 65212, United States
  • Siteman Cancer Center at West County Hospital
    Creve Coeur, Missouri 63141, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Siteman Cancer Center-South County
    St Louis, Missouri 63129, United States
  • Memorial Sloan Kettering Monmouth
    Middletown, New Jersey 07748, United States
  • University of New Mexico Cancer Center
    Albuquerque, New Mexico 87102, United States
  • Memorial Sloan Kettering Commack
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Westchester
    East White Plains, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • UNC Lineberger Comprehensive Cancer Center
    Chapel Hill, North Carolina 27599, United States
  • Carolinas Medical Center/Levine Cancer Institute
    Charlotte, North Carolina 28203, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • East Carolina University
    Greenville, North Carolina 27834, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • University of Cincinnati/Barrett Cancer Center
    Cincinnati, Ohio 45219, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • UT Southwestern/Simmons Cancer Center-Dallas
    Dallas, Texas 75390, United States
  • Memorial Hermann Texas Medical Center
    Houston, Texas 77030, United States
  • University Hospital
    San Antonio, Texas 78229, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
  • Froedtert Menomonee Falls Hospital
    Menomonee Falls, Wisconsin 53051, United States
  • Aurora Saint Luke's Medical Center
    Milwaukee, Wisconsin 53215, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
  • ProHealth D N Greenwald Center
    Mukwonago, Wisconsin 53149, United States
  • ProHealth Oconomowoc Memorial Hospital
    Oconomowoc, Wisconsin 53066, United States
  • ProHealth Waukesha Memorial Hospital
    Waukesha, Wisconsin 53188, United States
  • UW Cancer Center at ProHealth Care
    Waukesha, Wisconsin 53188, United States
  • Froedtert West Bend Hospital/Kraemer Cancer Center
    West Bend, Wisconsin 53095, United States
07

Registry details

Key details

Study ID
NCT03115333
Lead sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 14, 2017
Start date
Jul 25, 2017
Primary completion
Dec 31, 2025
Completion
May 7, 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

Jerrold Boxerman
principal investigator · ECOG-ACRIN Cancer Research Group

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
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