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

Launched by ECOG-ACRIN CANCER RESEARCH GROUP · Apr 10, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a special type of brain imaging called dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) to see how well it can measure blood flow changes in the brain for patients with a recurring type of brain cancer known as glioblastoma. The goal is to find out if this imaging method can help doctors determine how well patients are responding to a treatment called bevacizumab, which is used to help shrink tumors.

To participate, patients need to have a confirmed diagnosis of glioblastoma or gliosarcoma and be in relatively good health, as shown by their ability to perform daily activities. They should not have had certain previous treatments or specific medical conditions that could affect the imaging results. Participants can expect to undergo brain scans while receiving bevacizumab, either alone or with other chemotherapy, and will be monitored closely for their response to the treatment. It’s important for potential participants to discuss with their doctors whether they meet the criteria and if this trial could be a good option for them.

Gender

ALL

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)