DSC-MRI for Recurrent Glioblastoma

Not currently recruiting at 61 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: ECOG-ACRIN Cancer Research Group
Must be taking: Bevacizumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well a special MRI technique, DSC-MRI, measures blood flow changes in brain cancer, specifically glioblastoma, after treatment with bevacizumab (also known as Avastin). Bevacizumab targets blood vessels in tumors to slow their growth. The trial seeks participants whose glioblastoma has returned after initial treatment and who have not previously received certain immunotherapies. Participants should be comfortable with MRI scans and must not have any non-removable metal in their bodies.

As an unphased trial, this study offers a unique opportunity to contribute to cutting-edge research that could improve future treatment options for glioblastoma patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you have not been previously treated with immunotherapies.

What prior data suggests that DSC-MRI is safe for measuring response to bevacizumab in glioblastoma patients?

Research has shown that bevacizumab is generally well-tolerated by patients with glioblastoma. While side effects occur, they are often manageable. Common side effects include high blood pressure, nosebleeds, and headaches, but these are usually not life-threatening.

The FDA has already approved bevacizumab for treating certain cancers, indicating a known safety profile. However, because reactions can vary, regular check-ups with healthcare professionals remain important.

Regarding DSC-MRI, studies indicate it is safe for patients. This imaging technique checks blood flow in the brain and monitors tumor response to treatment. No major safety concerns have been reported with this method. Overall, both the treatment and the imaging technique have a good safety record according to existing studies.12345

Why are researchers excited about this trial?

Unlike the standard care options for recurrent glioblastoma, which often involve surgery, radiation, and chemotherapy, this trial is exploring the use of DSC-MRI in combination with bevacizumab. Researchers are excited because DSC-MRI is a novel imaging technique that can provide detailed information about blood flow in the brain. This could allow doctors to assess how well bevacizumab, a drug that targets blood vessel growth, is working much earlier than traditional methods. By using DSC-MRI, they hope to tailor treatments more effectively and improve outcomes for patients.

What evidence suggests that DSC-MRI is effective for measuring response to bevacizumab in recurrent glioblastoma?

Research has shown that bevacizumab, which participants in this trial may receive, can help treat recurrent glioblastoma by targeting the blood vessels that feed the tumor. It blocks a protein that aids these blood vessels' growth, potentially starving the tumor. Studies have found that bevacizumab can shrink the tumor and slow its growth in some patients with glioblastoma. In this trial, doctors will use a special type of MRI scan, called DSC-MRI, to monitor changes in blood flow to the tumor. This scan can help determine how well bevacizumab is working. Previous research has shown that changes in blood flow, measured by this scan, can indicate how the tumor responds to the treatment. This helps doctors assess the treatment's effectiveness early on.26789

Who Is on the Research Team?

JB

Jerrold Boxerman

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

This trial is for adults with recurrent glioblastoma who can undergo MRI scans and have not been treated with immunotherapies. They must have a Karnofsky performance status of at least 70, no severe allergies to gadolinium, no MR-incompatible implants, and adequate organ function. Pregnant or breastfeeding women are excluded.

Inclusion Criteria

I have never received immunotherapy treatments.
My kidneys work well (eGFR >= 40).
My weight is within the limit for an MRI scanner table.
See 12 more

Exclusion Criteria

Progressive enhancement on MRI within specified timeframes
I am not taking bevacizumab for reasons unrelated to cancer treatment.
Intratumoral hemorrhage as seen on hemosiderin-sensitive MRI
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Patients undergo DSC-MRI within 3 days before bevacizumab initiation

1 week
1 visit (in-person)

Treatment

Patients receive bevacizumab and undergo DSC-MRI at day 15 to measure changes in rCBV

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for overall survival and progression-free survival

Up to 5 years
Every 3 months for 1 year, then every 6 months for up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Trial Overview The study tests how well DSC-MRI measures blood volume changes in the brain as an early indicator of response to Bevacizumab treatment in patients experiencing their first recurrence of glioblastoma.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Diagnostic (DSC-MRI)Experimental Treatment1 Intervention

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺
Approved in European Union as Avastin for:
🇺🇸
Approved in United States as Avastin for:
🇯🇵
Approved in Japan as Avastin for:
🇨🇦
Approved in Canada as Avastin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials
122
Recruited
160,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 13 patients with recurrent glioblastoma multiforme, relative cerebral blood volume (rCBV) measured by dynamic susceptibility contrast MRI was found to be a significant predictor of progression-free survival (PFS) both before and after starting bevacizumab treatment.
Patients with lower rCBV values (less than 4.50 mL/100g at baseline and less than 1.83 mL/100g after treatment) experienced longer PFS, indicating that rCBV can be a reliable biomarker for assessing the effectiveness of antiangiogenic therapy in this patient population.
Prognostic value of relative cerebral blood volume in patients with recurrent glioblastoma multiforme treated with bevacizumab.Stecco, A., Amatuzzo, P., Sponghini, AP., et al.[2020]
In a study of 74 patients with recurrent glioblastoma treated with bevacizumab (BEV), 34% developed T1-hyperintense lesions and 47% had diffusion-restricted lesions, indicating significant imaging changes associated with treatment.
Patients with both T1-hyperintense and diffusion-restricted lesions (28% of the cohort) had a notably longer overall survival of 13.0 months compared to 6.6 months for those without these lesions, suggesting that these double-positive lesions may indicate effective antitumor activity and better local control of the disease.
Sustained focal antitumor activity of bevacizumab in recurrent glioblastoma.Bähr, O., Harter, PN., Weise, LM., et al.[2022]
In a study of 127 patients with recurrent glioblastoma, baseline relative cerebral blood volume (rCBV) was found to be a strong predictor of progression-free survival (PFS) and overall survival (OS) in patients treated with bevacizumab, with 82% of patients achieving 6-month PFS and 79% achieving 12-month OS based on rCBV levels.
The study demonstrated that rCBV is a more effective predictive biomarker for treatment response to bevacizumab compared to conventional MRI volumetric analysis, as it was not associated with survival outcomes in patients receiving alkylating chemotherapy.
Relative cerebral blood volume is a potential predictive imaging biomarker of bevacizumab efficacy in recurrent glioblastoma.Kickingereder, P., Wiestler, B., Burth, S., et al.[2018]

Citations

results from the ACRIN 6677/RTOG 0625 multicenter trial - PMCThe study goal was to determine whether changes in relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI ...
Radiomics-based neural network predicts recurrence ...We propose two different neural network models to predict the recurrence patterns in glioblastoma that utilizes high-dimensional radiomic profiles based on ...
Assessing the diagnostic accuracy and interobserver ...This retrospective study included adults with histology-proven glioblastoma who underwent an index DSC MRP examination following treatment.
Dynamic Contrast-enhanced MRI Processing Comparison ...We compared DCE-MRI processing methods for distinguishing true disease progression from pseudoprogression in high-grade gliomas (HGGs).
Dynamic Susceptibility Contrast-Enhanced MR Perfusion ...In the present study, DSC-MRP was used to assess tumor response in 25 patients with recurrent GBM treated with SIACI BV. rCBV and rCBF were ...
Role of Dynamic Susceptibility Contrast Perfusion MRI in ...This study aims to explore if dynamic susceptibility contrast- (DSC-) MRI can improve the evaluation of glioma progression.
Implementation and evaluation of a dynamic contrast ...In this study we demonstrate the implementation of a post-contrast 3DT1-weighted (3D-T1w) and dynamic contrast-enhancement (DCE) protocol to assess glioblastoma ...
Added value of dynamic contrast-enhanced MR imaging in ...The purpose of our study was to develop a multiparametric deep learning model based on DCE and conventional MR imaging for prediction of local recurrence.
The QIBA Profile for Dynamic Susceptibility Contrast MRI ...The dynamic susceptibility contrast (DSC) MRI measures of relative cerebral blood volume (rCBV) play a central role in monitoring therapeutic response and ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security