NCT03115333

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. 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: I. 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. V. 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.

Conditions

• Gliosarcoma
• Recurrent Glioblastoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging	Undergo DSC-MRI

Timeline

• Start date: 2017-07-25
• Primary completion: 2025-12-31
• Completion: 2027-05-07
• First posted: 2017-04-14
• Last updated: 2026-04-03

Locations

58 sites across 1 country: United States

Regulatory

• FDA-regulated device study