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

Must not be taking: Immunotherapies

Disqualifiers: Pregnancy, Intratumoral hemorrhage, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

Who Is on the Research Team?

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.

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

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?

Group I: Diagnostic (DSC-MRI) Experimental Treatment 1 Intervention

Patients undergo DSC-MRI within 3 days before bevacizumab initiation and at day 15.

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

Approved in European Union as Avastin for:

• Colorectal cancer
• Breast cancer
• Non-small cell lung cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in United States as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Glioblastoma
• Renal cell carcinoma
• Cervical cancer
• Ovarian cancer

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 24 patients with recurrent glioblastoma treated with bevacizumab, a reduction in tumor leakage observed through DSC perfusion MRI at 8 weeks significantly predicted longer overall survival (OS) and progression-free survival (PFS).

Higher baseline leakage levels were linked to a greater reduction in leakage after treatment, suggesting that baseline leakage could serve as a potential biomarker for predicting treatment response, although it was not directly associated with survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leakage decrease detected by dynamic susceptibility-weighted contrast-enhanced perfusion MRI predicts survival in recurrent glioblastoma treated with bevacizumab. Hilario, A., Sepulveda, JM., Hernandez-Lain, A., et al.[2022]

Bevacizumab, a monoclonal antibody targeting VEGF, has shown improved patient outcomes in recurrent glioblastoma (GBM) when used in combination with chemotherapy, leading to its accelerated approval by the FDA based on positive results from phase 2 studies.

The treatment is associated with manageable toxicity, as severe adverse events occur in only a small percentage of patients, making it a safer option for those with recurrent GBM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab for the treatment of recurrent glioblastoma. Chamberlain, MC.[2023]

In a study of 36 patients with recurrent high-grade gliomas, pre- and posttreatment relative cerebral blood volume (rCBV) measurements from dynamic MRI were found to be significant predictors of overall survival (OS) and progression-free survival (PFS) when treated with bevacizumab.

Patients with a posttreatment rCBV below 4400 had a significantly longer OS (340 days) compared to those above this threshold (186 days), indicating that lower rCBV values correlate with better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic-susceptibility contrast agent MRI measures of relative cerebral blood volume predict response to bevacizumab in recurrent high-grade glioma. Schmainda, KM., Prah, M., Connelly, J., et al.[2022]

In a study of 258 patients with malignant glioma treated with bevacizumab, the incidence of severe adverse drug reactions was 15.1%, with specific concerns including cerebral bleeding and infections, indicating a manageable safety profile.

The 1-year survival rate for newly diagnosed glioblastoma patients was 78%, suggesting that bevacizumab is effective and comparable to previous clinical trial results, making it a viable treatment option in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of bevacizumab in Japanese patients with malignant glioma: a post-marketing surveillance study. Motoo, N., Hayashi, Y., Shimizu, A., et al.[2020]

Bevacizumab, used to treat glioblastoma and other tumors, has a unique toxicity profile that can lead to serious side effects like gastrointestinal perforation and intracranial hemorrhages, particularly in glioblastoma patients.

The study systematically reviewed these adverse events, identifying risk factors and suggesting preventive and therapeutic measures to reduce treatment-related complications, emphasizing the need for careful monitoring in patients receiving this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical management of bevacizumab-related toxicities in glioblastoma. Brandes, AA., Bartolotti, M., Tosoni, A., et al.[2022]

The study created a large-scale radiographic atlas of cerebral blood volume (CBV) using data from 450 patients, which helps in assessing treatment responses in glioblastoma patients more accurately than traditional methods.

In 32 recurrent glioblastoma patients treated with bevacizumab, specific CBV metrics from the atlas, such as a hypervascular tumor volume greater than 2.35 cc before treatment, were linked to shorter progression-free survival (PFS) and overall survival (OS), indicating that this atlas can provide valuable prognostic information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypervascular tumor volume estimated by comparison to a large-scale cerebral blood volume radiographic atlas predicts survival in recurrent glioblastoma treated with bevacizumab. Leu, K., Enzmann, DR., Woodworth, DC., et al.[2019]

In a study of 11 patients with recurrent glioblastoma, the use of 18F-fluoroethyl-L-tyrosine (FET) PET imaging showed that a high post-treatment-to-pretreatment FET uptake ratio was linked to poorer progression-free survival (PFS) and overall survival (OS), indicating its potential as a prognostic tool.

The correlation between FET PET uptake and MRI contrast-enhanced T1 signal intensity was moderate, suggesting that while FET PET can provide valuable information, it may not fully differentiate between tumor vascular normalization and actual antitumor effects after bevacizumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voxel-Wise Analysis of Fluoroethyltyrosine PET and MRI in the Assessment of Recurrent Glioblastoma During Antiangiogenic Therapy. George, E., Kijewski, MF., Dubey, S., et al.[2019]

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