Metabolic MRI for Brain Tumor

Overseen By Saima Chaabane

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Cannot safely perform MRI, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new use of MRI technology to better visualize and understand gliomas, a type of brain tumor. The goal is to develop an advanced imaging method, Simultaneous Multinuclear Metabolic MRI, to enhance early detection, diagnosis, and treatment plans for brain cancer. Participants include healthy volunteers for comparison and those with gliomas, particularly if the tumor is newly diagnosed or has recurred. Ideal candidates have a diagnosed glioma and are scheduled for surgery or receiving immunotherapy treatments. As an Early Phase 1 trial, this research aims to understand how this new imaging method functions in people, offering participants a chance to contribute to groundbreaking advancements in brain cancer diagnostics.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this MRI technique is safe for brain tumor patients?

Research has shown that Simultaneous Multinuclear Metabolic MRI is a new imaging type being tested for safety and effectiveness in brain tumor cases. Direct safety data from past studies is unavailable because it remains in early testing stages. With limited safety information available, traditional MRI, the basis for this new method, is generally considered safe and non-invasive. Although this new method might present more unknowns, the basic technology is usually well-tolerated. More testing is necessary to fully understand any potential risks or side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Metabolic MRI technique for brain tumors because it offers a unique way to visualize and understand tumor metabolism in real-time. Unlike standard MRI scans, which primarily provide structural images, this method uses multinuclear metabolic imaging to capture the chemical processes within the tumor. This can help doctors monitor how a tumor responds to treatments like immunotherapy more precisely. By providing detailed metabolic information, this approach has the potential to significantly enhance treatment planning and outcomes for patients with brain tumors.

What evidence suggests that this MRI technique is effective for brain tumors?

Research has shown that Simultaneous Multinuclear Metabolic MRI is a new imaging technique under study for brain tumors like glioma. This MRI method examines different signals in the brain, potentially identifying changes in the tumor's energy use. In this trial, participants will undergo this imaging technique to monitor tumor changes before and after treatments such as immunotherapy. Early findings suggest it could enhance how doctors diagnose and plan treatment for glioma. Although still in the early research stages, this technology aims to improve early detection and treatment planning. ^{1 5 6 7 8}

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 newly diagnosed or recurrent glioma, a type of brain tumor. Healthy volunteers are also needed for part of the study. Participants must be able to safely undergo MRI scans and have tumors measurable at least 1cm in size. Those receiving immunotherapy for recurrent glioma can join too.

Inclusion Criteria

I am 18 or older with a suspected or confirmed glioma, indicated for surgery, and my tumor is larger than 1cm³.

I am over 18 and do not have any brain tumors or neurological diseases.

I am 18 or older with recurrent glioma and am in an immunotherapy trial or need immunotherapy.

Exclusion Criteria

I am under 18 or cannot safely have an MRI with contrast.

I am under 18 or cannot safely have an MRI with contrast.

I am under 18 and cannot safely have an MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Tissue Collection

Patients undergo MRI and collection of tissue samples for IHC analysis

Up to 5 years

Metabolic Imaging and Immunotherapy

Patients undergo multinuclear metabolic imaging before and after immunotherapy and prior to surgical resection

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Simultaneous Multinuclear Metabolic MRI

Trial Overview The trial is testing a new multinuclear metabolic MRI sequence designed to improve early detection, diagnosis, prognosis, and treatment planning in brain cancer patients. It involves biospecimen collection and diagnostic imaging using this novel technology.

How Is the Trial Designed?

Group I: Basic science (MRI, metabolic imaging, tissue collection) Experimental Treatment 3 Interventions

AIM 1: Previous scan data from healthy subjects is collected and analyzed. AIM 2: Patients undergo MRI. Patients also undergo collection of tissue samples for IHC analysis. AIM 3: Patients undergo multinuclear metabolic imaging before and after immunotherapy and prior to surgical resection.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Simultaneous MR-PET imaging is feasible for metabolic mapping of gliomas, allowing for better identification of the most malignant tumor areas before surgery in 28 patients.

High methionine uptake ratios do not always correlate with other metabolic markers like choline/N-acetylaspartate, indicating that different metabolic changes in gliomas should be considered when planning surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic mapping of gliomas using hybrid MR-PET imaging: feasibility of the method and spatial distribution of metabolic changes. Bisdas, S., Ritz, R., Bender, B., et al.[2016]

Magnetic resonance techniques, including NMR and MRS, are crucial for profiling the unique metabolism of brain tumors, which can help identify new vulnerabilities and monitor disease progression in patients.

The use of 13C hyperpolarized MRSI has emerged as a powerful tool for detecting metabolic changes in tumors, allowing for better monitoring of treatment responses and potentially guiding therapy adjustments in brain cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance spectroscopy for the study of cns malignancies. Ruiz-Rodado, V., Brender, JR., Cherukuri, MK., et al.[2021]

Multinuclear magnetic resonance spectroscopy (MRS) is a powerful tool for studying tumor biochemistry, particularly in understanding how tumor growth is influenced by bioenergetics and lipid metabolite concentrations.

The technology's ability to analyze diverse metabolic responses in tumors during anticancer treatments provides valuable insights that can enhance our understanding of cancer behavior and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance spectroscopy of neoplasms. Maris, JM., Chance, B.[2015]

A new method using Manganese-Enhanced Magnetic Resonance Imaging (MEMRI) allows for rapid and accurate detection of optic glioma in a mouse model of neurofibromatosis-1, improving the ability to study small tumors in vivo.

In a study involving 23 mice, the presence, size, and shape of optic gliomas were correctly identified, making this technique valuable for future preclinical drug evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection and measurement of neurofibromatosis-1 mouse optic glioma in vivo. Banerjee, D., Hegedus, B., Gutmann, DH., et al.[2018]

A pilot trial involving 30 patients with newly diagnosed glioblastomas (GBMs) demonstrated that sMRI-guided radiation therapy (RT) dose escalation to 75 Gy is feasible and safe, with promising median overall survival of 23.0 months and progression-free survival of 16.6 months.

The study found that most severe toxicities were related to temozolomide (TMZ) rather than the escalated RT, indicating that the new treatment approach may be well-tolerated and justifies further investigation in a randomized phase II trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-institutional pilot clinical trial of spectroscopic MRI-guided radiation dose escalation for newly diagnosed glioblastoma. Ramesh, K., Mellon, EA., Gurbani, SS., et al.[2023]

The review highlights various techniques for studying metabolism in brain cancer, including established methods like proton magnetic resonance spectroscopy and emerging techniques such as hyperpolarized metabolic imaging and chemical exchange saturation transfer.

These advanced imaging techniques are currently in clinical trials, suggesting they could significantly enhance brain cancer diagnosis and treatment assessment by integrating metabolomics with genomics and proteomics for a comprehensive understanding of tumor development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interrogating Metabolism in Brain Cancer. Salzillo, TC., Hu, J., Nguyen, L., et al.[2018]

Magnetic Resonance Spectroscopy (MRS) can effectively monitor the metabolic changes in astrocytic tumors during radiation therapy, showing a progressive decrease in metabolic ratios over time after treatment.

There is a positive correlation between tumor volume changes and specific metabolic ratios (like Cho/Cr and lactate/Cr) on the 4th day after radiation therapy, indicating that these imaging biomarkers can help predict how well the tumors respond to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic factor from MR spectroscopy in rat with astrocytic tumour during radiation therapy. Yu, TG., Feng, Y., Feng, XY., et al.[2018]

Using surface coil MRI combined with localized spectroscopy, researchers successfully detected metabolic changes in malignant gliomas in rats, highlighting a noninvasive method to study brain tumors.

The study found significant decreases in N-acetyl-aspartate and creatine levels, along with increased lactic acid or lipids in gliomas compared to normal brain tissue, indicating distinct metabolic abnormalities associated with these tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spatially localized in vivo 1H magnetic resonance spectroscopy of an intracerebral rat glioma. Ross, BD., Merkle, H., Hendrich, K., et al.[2019]

The combination of temozolomide (TMZ) with standard radiation therapy improves survival rates in patients with high-grade gliomas, but local tumor recurrence remains a significant issue.

Functional and metabolic imaging techniques, such as advanced MRI and PET scans, can identify tumor areas that are at higher risk for failure, potentially leading to better-targeted treatment strategies beyond what conventional imaging can provide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and metabolic magnetic resonance imaging and positron emission tomography for tumor volume definition in high-grade gliomas. Tsien, CI., Cao, Y., Lawrence, TS.[2021]

Magnetic resonance (MR) spectroscopy is a valuable tool for metabolic imaging of brain tumors, providing insights from both preclinical models and clinical applications.

The review highlights various MR spectroscopy techniques, including (1)H, (31)P, and (13)C MRS, which enhance our understanding of glioma biology and improve tumor characterization and monitoring in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance (MR) Metabolic Imaging in Glioma. Chaumeil, MM., Lupo, JM., Ronen, SM.[2023]

Magnetic resonance techniques, such as MRI and MRS, are valuable for studying tumor metabolism and pathophysiology, which can enhance the development and application of cancer therapies.

These methods allow for the non-invasive assessment of tumors, helping to identify metabolic changes, therapeutic responses, and optimize treatment combinations, ultimately improving our understanding of how tumors respond to therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of magnetic resonance in model systems: cancer therapeutics. Evelhoch, JL., Gillies, RJ., Karczmar, GS., et al.[2019]

Spectroscopic MRI (sMRI) can improve the identification of high tumor burden areas in glioblastoma patients, potentially leading to better-targeted radiation therapy (RT) and reducing the risk of local recurrence.

The Brain Imaging Collaboration Suite (BrICS) has been successfully implemented in a pilot study involving 18 patients, showing feasibility and safety in using sMRI for RT planning, with no severe toxicities reported so far.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Brain Imaging Collaboration Suite (BrICS): A Cloud Platform for Integrating Whole-Brain Spectroscopic MRI into the Radiation Therapy Planning Workflow. Gurbani, S., Weinberg, B., Cooper, L., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05045027

NCT05045027 | Simultaneous Multinuclear Metabolic MRI ... This clinical trial constructs and tests a novel multinuclear metabolic magnetic resonance imaging (MRI) sequence in patients with glioma (brain tumor) that is ...

2. trials.braintumor.org trials.braintumor.org/trials/NCT05045027

Simultaneous Multinuclear Metabolic MRI in Newly ... This clinical trial constructs and tests a novel multinuclear metabolic magnetic resonance imaging (MRI) sequence in patients with glioma (brain tumor) that is ...

3. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1190856.pdf

Simultaneous Multinuclear (Na+/H+) Metabolic MRI For ... - DTIC This form of aerobic glycolysis results in a significant decrease in extracellular pH due to increased concentration of lactic acid and other factors.

4. clinicaltrial.be clinicaltrial.be/en/details/39197?per_page=20&only_recruiting=0&only_eligible=0

Simultaneous Multinuclear Metabolic MRI in Newly ... Will examine the correlation between baseline tumor metabolism and change in metabolism with respect to overall survival using Cox multivariable ...

5. clinconnect.io clinconnect.io/trials/NCT05045027

Simultaneous Multinuclear Metabolic MRI in Newly This clinical trial is studying a new type of MRI called multinuclear metabolic MRI to improve how we diagnose and understand gliomas, which are tumors in the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8967433/

Emerging MR Imaging and Spectroscopic Methods to Study ... The purpose of this review article is to summarize the potential clinical applications of these techniques in studying brain tumor metabolism.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9953338/

Magnetic Resonance Imaging of Primary Adult Brain Tumors This article aimed to provide an overview of neuroimaging in the assessment of adult primary brain tumors.

8. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-022-01262-z

Multi-nuclear magnetic resonance spectroscopy: state of the ... HP-[1-13C]-pyruvate MRI is a novel method for demonstrating energetic metabolism in the human brain and brain tumors, in contrast to the ...