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NCT03115333
DSC-MRI in Measuring rCBV for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma
Conditions: Gliosarcoma, Recurrent Glioblastoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 146
Sponsor: ECOG-ACRIN Cancer Research Group
Location: Saint Joseph's Hospital and Medical Center Phoenix Arizona
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.
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)
Source: ClinicalTrials.gov (NCT03115333). StuddyBuddy aggregates publicly available trial information.