DSC-MRI in Measuring Relative Cerebral Blood Volume 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.
Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma
- 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).
- 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.
- To determine whether baseline cerebral blood flow (CBF) or change in CBF is associated with OS or PFS.
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.
GliosarcomaRecurrent GlioblastomaGlioblastomaBevacizumabDynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
For people ages 18 years and up
- 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 m2 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
- UC Irvine Health/Chao Family Comprehensive Cancer Centeraccepting new patients
- Saint Joseph's Hospital and Medical Centeraccepting new patients
Lead Scientist at UC Irvine
- Daniel Chow
Authored (or co-authored) 24 research publications
- accepting new patients
- Start Date
- Completion Date
- ECOG-ACRIN Cancer Research Group
- Phase 2
- Study Type
- Last Updated
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