MRI for Glioblastoma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Pacemaker, Metal in body, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses MRI scans (Magnetic Resonance Imaging) to study brain tumors in patients with glioblastoma, a severe type of brain cancer. The goal is to identify which patients might benefit most from bevacizumab, a common but costly treatment. Participants must have a glioblastoma tumor that can be surgically removed and hasn't returned within three months of completing radiation therapy. The trial requires an MRI scan before surgery to observe specific markers in the brain. This research could help tailor treatments to individual patients, potentially improving outcomes. As an unphased trial, this study offers a unique opportunity to contribute to personalized treatment strategies for glioblastoma.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that MRI is safe for studying brain tumor biology in glioblastoma patients?

Previous studies have shown that MRI (magnetic resonance imaging) has been used safely in various medical procedures, including those for brain tumors. Research indicates that using MRI during glioma surgery doesn't cause major safety issues, although it may extend the surgery by about 42 minutes on average. Importantly, there were no significant reports of harmful side effects from the MRI itself.

In this trial, MRI is a common imaging technique used to better understand brain tumors. Findings suggest that MRI is well-tolerated, particularly because it is non-invasive. The main purpose of MRI here is to provide detailed images of the brain, aiding doctors in making better treatment decisions. Overall, based on existing data, participating in a trial using MRI should not pose significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using MRI for glioblastoma because it offers a non-invasive way to assess the tumor before surgery. Unlike traditional methods that might rely on invasive biopsies, MRI provides detailed images of the brain, helping surgeons plan procedures more accurately and potentially improving outcomes. This technique could lead to better-targeted treatments by allowing doctors to understand the tumor's characteristics and location without making an incision.

What evidence suggests that MRI is effective for studying glioblastoma?

Research shows that advanced MRI scans enhance understanding of glioblastoma and link these insights to patient outcomes. In this trial, participants will undergo an MRI scan during the screening process. MRI can predict how long a patient might live without cancer worsening and their overall survival. One study found that MRI accurately identifies patients with the condition 90% of the time and those without it 88% of the time. These findings suggest that MRI is a valuable tool in determining which patients might benefit from treatments like bevacizumab, helping to customize therapies and improve outcomes for glioblastoma patients. ^{4 6 7 8 9}

Who Is on the Research Team?

Benjamin M. Ellingson

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with new or returning glioblastoma, a type of brain tumor. Participants must have tumors larger than 1.5 mL that can be surgically removed and should not have had radiation therapy within the last three months.

Inclusion Criteria

I am older than 18 years.

I have a glioblastoma larger than 1.5 mL and need surgery, or my glioblastoma has recurred 3 months after radiation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Imaging

Participants undergo one MRI scan over approximately 1 hour prior to surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and surgery

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection
• Magnetic Resonance Imaging

Trial Overview

The study uses MRI scans to understand brain tumor biology in glioblastoma patients eligible for surgery. It aims to find out which patients might benefit from a drug called bevacizumab by analyzing MRI images and biomarkers.

How Is the Trial Designed?

Group I: Screening (MRI) Experimental Treatment 3 Interventions

Patients undergo one MRI scan over approximately 1 hour prior to surgery.

Magnetic Resonance Imaging is already approved in United States for the following indications:

Approved in United States as Lumakras (sotorasib) for:

• Non-small cell lung cancer with KRAS G12C mutation

Approved in United States as Vectibix (panitumumab) for:

• Advanced colorectal cancer that is wild-type RAS

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The use of a tri-cobalt-60 MRI-guided radiation therapy device allows for daily MRI scans during treatment for glioblastoma, enabling real-time monitoring of changes in tumor size and surrounding tissue.

Daily MRI scans showed a general trend of decreasing cavity measurements in postoperative patients, suggesting that this approach could enhance tumor targeting and minimize radiation exposure to healthy brain tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Tracking of Glioblastoma Resection Cavity, Cerebral Edema, and Tumor Volume with MRI-Guided Radiation Therapy. Mehta, S., Gajjar, SR., Padgett, KR., et al.[2020]

Intraoperative radiotherapy (IORT) using the INTRABEAM system was successfully performed on a 56-year-old female patient with recurrent glioblastoma multiforme, delivering a surface dose of 20 Gy, which is a promising approach for treating this aggressive brain tumor.

The novel (23)Na-MRI technique showed comparable effectiveness to (18)F-FET-PET in detecting tumor recurrence and provided additional insights beyond standard (1)H-MRI, indicating its potential as a valuable imaging tool in monitoring glioblastoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

²³Na-MRI of recurrent glioblastoma multiforme after intraoperative radiotherapy: technical note. Haneder, S., Giordano, FA., Konstandin, S., et al.[2018]

In a study of 61 glioblastoma patients undergoing 6 weeks of chemoradiation therapy, significant changes in tumor size and position were observed, with 40% of patients showing a decrease in tumor volume and notable migration distances greater than 5 mm during treatment.

These findings suggest that MRI-guided radiation therapy could enhance treatment outcomes by allowing for real-time adaptations to tumor dynamics, highlighting the importance of daily imaging in managing glioblastoma effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitating Interfraction Target Dynamics During Concurrent Chemoradiation for Glioblastoma: A Prospective Serial Imaging Study. Stewart, J., Sahgal, A., Lee, Y., et al.[2021]

In a study of 24 patients with glioblastoma, Ga-68 PSMA PET-CT imaging demonstrated a strong correlation with MRI for defining tumor volumes, with complete overlap in 17 cases, suggesting it is a reliable tool for treatment planning.

The use of Ga-68 PSMA PET-CT may lead to more accurate delineation of gross tumor volumes, potentially reducing radiation therapy side effects by avoiding unnecessary treatment of non-tumor areas affected by postoperative changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of Target Volumes on Magnetic Resonance Imaging and Prostate-Specific Membrane Antigen Brain Scans in the Treatment Planning of Glioblastomas. Lavanya, V., Malik, IM., Nallapareddy, K., et al.[2023]

The Río Hortega University Hospital Glioblastoma Dataset (RHUH-GBM) provides a comprehensive collection of multiparametric MRI images, molecular data, and survival information for glioblastoma patients, addressing gaps in existing public MRI repositories.

This dataset includes expert-corrected tumor segmentations, which are crucial for developing accurate algorithms to analyze postoperative and follow-up MRI scans, potentially improving patient outcomes in glioblastoma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Río Hortega University Hospital Glioblastoma dataset: A comprehensive collection of preoperative, early postoperative and recurrence MRI scans (RHUH-GBM). Cepeda, S., García-García, S., Arrese, I., et al.[2023]

Standard MRI techniques, including T1-weighted and T2-weighted sequences, are essential for diagnosing and managing glioblastoma, the most aggressive brain tumor, providing critical information about the tumor environment.

Advanced MRI modalities, such as dynamic contrast enhancement and diffusion tensor imaging, are being integrated into clinical practice to enhance glioblastoma characterization and support personalized treatment strategies, while also helping to minimize surgical risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced magnetic resonance imaging in glioblastoma: a review. Shukla, G., Alexander, GS., Bakas, S., et al.[2018]

Quantitative T1 relaxometry (qT1) offers a promising non-invasive alternative to gadolinium-based contrast agents (GBCA) for detecting tumor burden in glioblastoma patients, achieving a sensitivity of 86% and specificity of 80%.

This technique could potentially eliminate the risks associated with GBCA, such as adverse events and gadolinium deposition in brain tissue, while also providing insights into areas that may progress into tumor enhancement in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of quantitative magnetic resonance imaging T1-relaxometry in predicting contrast-enhancement in glioblastoma patients. Hattingen, E., Müller, A., Jurcoane, A., et al.[2018]

In a study involving eight patients over 24 months, functional imaging techniques like PET and fMRI were integrated into radiation therapy planning, showing potential to enhance treatment strategies for malignant glioma.

Functional imaging provided valuable insights that led to modifications in radiation therapy for two patients, suggesting it could improve treatment outcomes, although further research is needed to establish its prognostic value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional cerebral imaging in the evaluation and radiotherapeutic treatment planning of patients with malignant glioma. Pardo, FS., Aronen, HJ., Kennedy, D., et al.[2019]

In a study involving 11 patients with intracranial tumors, a dose of 0.1 mmol of gadolinium-DTPA/kg was found to be safe and effective for enhancing MR imaging of brain tumors, with no short-term side effects reported.

While a higher dose of 0.2 mmol/kg showed improved tumor visualization in some cases, it was only significantly beneficial in one patient, suggesting that the lower dose is generally sufficient for effective imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose administration of gadolinium-DTPA in MR imaging of intracranial tumors. Niendorf, HP., Laniado, M., Semmler, W., et al.[2021]

In a study of 10 glioblastoma patients undergoing radiation therapy, weekly adaptive planning using MRI-Linac systems significantly reduced radiation doses to healthy brain structures, particularly the hippocampi, compared to static planning.

The adaptive planning resulted in a maximum dose reduction to the hippocampi from 21 Gy to 15.2 Gy and a mean dose reduction from 12.5 Gy to 8.4 Gy, suggesting that this approach could help minimize neurocognitive side effects associated with radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulated Adaptive Radiotherapy for Shrinking Glioblastoma Resection Cavities on a Hybrid MRI-Linear Accelerator. Guevara, B., Cullison, K., Maziero, D., et al.[2023]

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