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GliosarcomaNCT03115333

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

A study testing Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging in people with Gliosarcoma and Recurrent Glioblastoma, run by ECOG-ACRIN Cancer Research Group at 58 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gliosarcoma, Recurrent Glioblastoma
What is being tested?
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
58 sitesUnited States
Study dates
25 Jul 2017to 7 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 17Show fewer
  • 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)

Who cannot join

None listed.

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

United States58 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Maryland Proton Treatment Center

    Baltimore, Maryland, 21201

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • University of Cincinnati/Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Northside Hospital-Forsyth

    Cumming, Georgia, 30041

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Memorial Sloan Kettering Westchester

    East White Plains, New York, 10604

  • East Carolina University

    Greenville, North Carolina, 27834

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • Saint Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • University Hospital

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Moffitt Cancer Center-International Plaza

    Tampa, Florida, 33607

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • ProHealth Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma

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:

  1. 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:

  1. 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.

  1. 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.

Being tested
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Medical subject headings
Gliosarcoma, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingDiagnostic test

    Also called DSC-MRI, Dynamic Susceptibility Contrast-Enhanced MRI, DYNAMIC SUSCEPTIBILITY-CONTRAST MRI

    Undergo DSC-MRI

Study groups in NCT03115333
Study groupRoleWhat they receive
Diagnostic (DSC-MRI)ExperimentalPatients undergo DSC-MRI within 3 days before bevacizumab initiation and at day 15.
Receives: Diagnostic Test: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

    Measured: Up to 5 years

Secondary outcomes (4)

  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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2017
  2. Study start25 Jul 2017
  3. Primary completion31 Dec 2025
  4. Study completion7 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03115333
Sponsor's protocol ID
EAF151
Other IDs
NCI-2016-01357, EAF151, EAF151, U10CA180820
Status last verified
Sep 2026
First submitted
10 Apr 2017
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging in people with Gliosarcoma and Recurrent Glioblastoma, run by ECOG-ACRIN Cancer Research Group at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in rCBV within enhancing tumor (time frame: Baseline to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03115333.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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