Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 5:39 PM
Study NCT ID:
NCT03115333
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-13
First Post:
2017-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DSC-MRI in Measuring rCBV for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Study Overview
Official Title:
Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2016-01357 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| EAF151 | OTHER | ECOG-ACRIN Cancer Research Group | View | |
| EAF151 | OTHER | CTEP | View | |
| U10CA180820 | NIH | None | https://reporter.nih.gov/quic… | View |