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Using MRI to Measure Blood Flow Changes in Glioblastoma Patients Treated with Bevacizumab

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

Not applicable Interventional Eastern Cooperative Oncology Group · NCT03115333

This study is testing if a special type of MRI can help doctors see how well a treatment called bevacizumab is working for people with recurring glioblastoma by measuring changes in blood flow in the brain.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment146 (estimated)
Ages18 Years and up
SexAll
SponsorEastern Cooperative Oncology Group Research network
Drugs / interventionsbevacizumab, chemotherapy, immunotherapy, radiation
Locations58 sites (Phoenix, Arizona and 57 other locations)
Trial IDNCT03115333 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) in measuring relative cerebral blood volume (rCBV) to assess early responses to bevacizumab in patients with recurrent glioblastoma. The study aims to determine if changes in rCBV from baseline to two weeks after treatment initiation correlate with overall survival and progression-free survival. Patients will undergo DSC-MRI before starting treatment and again at day 15, with follow-up assessments every three months for the first year and every six months for up to four years.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed recurrent glioblastoma or gliosarcoma who are eligible for bevacizumab therapy.

Not a fit: Patients who have previously received immunotherapies or those whose treatment is primarily aimed at reducing edema rather than targeting the tumor may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a reliable imaging biomarker for early response to treatment, potentially improving patient management and outcomes.

How similar studies have performed: Other studies have shown promising results using imaging biomarkers to assess treatment responses in glioblastoma, suggesting this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion 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)

Where this trial is running

Phoenix, Arizona and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions GliosarcomaRecurrent Glioblastoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.