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

Trial Summary

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 data supports the effectiveness of the treatment involving MRI for Glioblastoma?

Research shows that using MRI during radiation therapy for glioblastoma helps track changes in the tumor and surrounding brain tissue, allowing for better targeting of the tumor and sparing healthy brain areas. This approach can potentially improve treatment outcomes by adapting to tumor changes over time. ^{1 2 3 4 5}

Is MRI safe for use in glioblastoma treatment?

MRI is generally safe for use in glioblastoma treatment, but the use of gadolinium-based contrast agents (GBCA) in MRI can have a 2.4% rate of adverse events, including serious conditions like nephrogenic systemic fibrosis (NSF). However, studies have shown that a dose of 0.1 mmol of gadolinium-DTPA/kg is safe for brain-tumor imaging, with only slight, temporary changes in serum iron levels. ^{5 6 7 8 9}

How does the treatment using MRI for glioblastoma differ from other treatments?

The use of MRI in glioblastoma treatment is unique because it allows for advanced imaging techniques that provide detailed information about the tumor environment, which can improve personalized therapy approaches. Unlike traditional treatments, MRI-guided radiation therapy enables daily tracking of tumor changes, potentially improving targeting and reducing damage to healthy brain tissue. ^{2 4 5 6 10}

What is the purpose of this trial?

This clinical trial uses a type of imaging scan called magnetic resonance imaging (MRI) to study brain tumor biology in patients with glioblastoma that can be removed by surgery (resectable). Malignant gliomas are the second leading cause of cancer mortality in people under the age of 35 in the United States. Glioblastoma is a type of malignant glioma with very poor patient prognosis. There are currently only about 3 drugs approved by the Food and Drug Administration (FDA) for the treatment of glioblastoma, one of them being administration of bevacizumab, which is very expensive. It is the most widely used treatment for glioblastoma with dramatic results. However, previous clinical trials have not demonstrated an overall survival benefit across all patient populations with glioblastoma that has returned after treatment (recurrent). The study aims to identify which patients who will benefit from bevacizumab therapy by observing MRI images and corresponding imaging biomarkers.

Research Team

Benjamin M. Ellingson

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

²³Na-MRI of recurrent glioblastoma multiforme after intraoperative radiotherapy: technical note. [2018]

2. China pubmed.ncbi.nlm.nih.gov

Advanced magnetic resonance imaging in glioblastoma: a review. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Quantitating Interfraction Target Dynamics During Concurrent Chemoradiation for Glioblastoma: A Prospective Serial Imaging Study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Functional cerebral imaging in the evaluation and radiotherapeutic treatment planning of patients with malignant glioma. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Daily Tracking of Glioblastoma Resection Cavity, Cerebral Edema, and Tumor Volume with MRI-Guided Radiation Therapy. [2020]

6. India 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Dose administration of gadolinium-DTPA in MR imaging of intracranial tumors. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Value of quantitative magnetic resonance imaging T1-relaxometry in predicting contrast-enhancement in glioblastoma patients. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Simulated Adaptive Radiotherapy for Shrinking Glioblastoma Resection Cavities on a Hybrid MRI-Linear Accelerator. [2023]

10. Netherlands 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). [2023]