MRI + MRSI for Brain Tumor

Overseen By Wendy Ma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Susan Chang

Disqualifiers: Congestive heart failure, Myocardial infarction, HIV, others

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

Compensation: Varies

Number of Visits: 1

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how certain MRI methods can help understand and evaluate lower-grade brain tumors called gliomas. By using advanced imaging techniques, researchers hope to identify changes in the tumors, potentially leading to improved monitoring and treatment methods. Suitable candidates for this trial include individuals with a confirmed lower-grade glioma who are either under regular surveillance or require treatment for a suspected recurring tumor. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants an opportunity to contribute to groundbreaking advancements in glioma care.

Will I have to stop taking my current medications?

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

What prior data suggests that MRI and MRSI are safe for characterizing brain tumors?

Research has shown that Magnetic Resonance Imaging (MRI) is generally safe. It avoids ionizing radiation, which can be harmful in large amounts. Before undergoing an MRI, patients must complete a safety check to ensure no metal is present in their body, as this could pose a risk.

Magnetic Resonance Spectroscopic Imaging (MRSI), used alongside MRI in this study, is also considered safe. MRSI is non-invasive, meaning it doesn't involve surgery or entering the body. It allows doctors to examine the chemical makeup of brain tumors without performing invasive procedures.

Both MRI and MRSI are commonly used in hospitals and are generally well-tolerated by patients. Although this trial is in its early stages, the use of these tests in medical settings suggests a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using MRI combined with Magnetic Resonance Spectroscopic Imaging (MRSI) for brain tumors because it offers a more detailed look at the tumor's chemical makeup. Unlike standard MRI, which mainly shows the structure of the brain, MRSI can provide insights into the tumor's metabolic activity, helping doctors understand how aggressive it is. In Cohort 2, the treatment is even more advanced with the addition of hyperpolarized carbon C 13 pyruvate. This compound enhances the MRSI signals, potentially allowing for real-time monitoring of treatment effectiveness. This approach could lead to more personalized and timely treatment decisions for patients with brain tumors.

What evidence suggests that MRI and MRSI are effective for characterizing lower grade glioma?

In this trial, participants will undergo MRI (magnetic resonance imaging) and MR spectroscopic imaging (MRSI) to assess brain tumors. Previous studies have shown that MRI accurately detects and precisely locates brain tumors. MRSI offers additional insights into brain activity, aiding in diagnosing and tracking tumor changes. One study found that combining MRSI with MRI increased the accuracy of diagnosing uncertain brain lesions from 55% to 71%. Together, these imaging methods provide a detailed view of brain tumors and may enhance tumor assessment and monitoring. ^{2 6 7 8 9}

Who Is on the Research Team?

Susan Chang, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with lower grade glioma who are either being monitored or scheduled for treatment due to tumor recurrence. They must have a life expectancy over 12 weeks, be in good physical condition (Karnofsky score >60), not have severe heart issues, HIV, other cancers (except certain skin cancers/cervical carcinoma in-situ), and no major uncontrolled illnesses. Pregnant/breastfeeding women are excluded; others must use effective contraception.

Inclusion Criteria

I haven't had a heart attack or unstable chest pain in the last year.

Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation

My kidney function is good, with creatinine below 1.5 mg/dL.

Exclusion Criteria

Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Patients undergo MRI and MRSI scans at baseline to establish initial measurements

1 hour

1 visit (in-person)

Treatment/Monitoring

Patients receive hyperpolarized carbon C 13 pyruvate and continue with MRSI scans following clinical MRI schedule

Up to 4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Resonance Imaging
• Magnetic Resonance Spectroscopic Imaging

Trial Overview

The study tests how well serial MR imaging and MR spectroscopic imaging can track changes in lower grade gliomas over time. It aims to improve the evaluation of brain tumors and standardize treatments by using these advanced diagnostic procedures.

How Is the Trial Designed?

Group I: Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI) Experimental Treatment 3 Interventions

Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.

Group II: Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT) Experimental Treatment 2 Interventions

Patients undergo MRI and MRSI scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist

Who Is Running the Clinical Trial?

Susan Chang

Lead Sponsor

Trials

5

Recruited

520+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Phillips-Medisize

Collaborator

Trials

1

Recruited

300+

Sigma-Aldrich

Collaborator

Trials

2

Recruited

370+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Published Research Related to This Trial

Magnetic resonance spectroscopy (MRS) can provide a more accurate diagnosis of intracranial tumors compared to conventional MRI by analyzing key metabolites in brain tissue, such as N-acetyl aspartate and choline, which change in response to different pathological conditions.

MRS has clinical applications in diagnosing tumors, assessing the level of malignancy in gliomas, and monitoring for tumor recurrence, making it a valuable tool in the management of brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contribution of magnetic resonance spectrometry to the diagnosis of intracranial tumors]. Galanaud, D., Nicoli, F., Le Fur, Y., et al.[2015]

In a study of 16 patients with recurrent malignant glioma receiving tamoxifen chemotherapy, specific metabolic changes detected by proton magnetic resonance spectroscopic imaging (1H-MRSI) could predict treatment failure up to 8 weeks before clinical signs appeared.

Responders to treatment showed stable metabolite levels, while non-responders exhibited significant increases in metabolites like lactate and choline, indicating that monitoring these changes could help guide timely adjustments in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective serial proton MR spectroscopic assessment of response to tamoxifen for recurrent malignant glioma. Sankar, T., Caramanos, Z., Assina, R., et al.[2021]

Magnetic resonance spectroscopy (MRS) can effectively complement magnetic resonance imaging (MRI) by detecting metabolic changes in brain tumors, helping to classify them more accurately.

MRS is reproducible and can be used for ongoing monitoring of treatment, as well as guiding neurosurgeons to target the most aggressive tumor areas, potentially reducing unnecessary surgeries and associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(1)H MR spectroscopy of human brain tumours: a practical approach. Callot, V., Galanaud, D., Le Fur, Y., et al.[2021]

Using a 3 T MRI scanner with an eight-channel phased-array head coil significantly improves the signal-to-noise ratio (SNR) by over 2.33 times compared to a 1.5 T scanner with a quadrature head coil, enhancing the quality of magnetic resonance spectroscopic imaging (MRSI) data.

This increased SNR is crucial for clinical applications in brain tumor patients, as it allows for either reduced acquisition times or improved spatial resolution, potentially leading to better diagnostic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations in applying 3D PRESS H-1 brain MRSI with an eight-channel phased-array coil at 3 T. Li, Y., Osorio, JA., Ozturk-Isik, E., et al.[2007]

A semi-automated MR spectroscopic imaging (MRSI) technique was used to analyze 20 intracranial tumors and 15 non-neoplastic diseases, successfully distinguishing between the two based on normalized choline (nCho) ratios.

Intracranial tumors showed significantly elevated nCho ratios (mean 1.91) compared to non-neoplastic diseases (mean 0.91), indicating that this method can effectively differentiate tumors from non-tumor conditions, although there was a 13% false positive rate in non-neoplastic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multivoxel MR spectroscopic imaging--distinguishing intracranial tumours from non-neoplastic disease. Nagar, VA., Ye, J., Xu, M., et al.[2020]

Proton magnetic resonance spectroscopic imaging (1H MRSI) at 3 Tesla (3T) provides a significant increase in signal-to-noise ratio (SNR), allowing for clinically relevant data to be obtained in just 5 to 10 minutes, compared to 17 minutes at 1.5T.

The study found that the choline to N-acetyl aspartate ratio (Cho/NAA) was significantly higher in tumor lesions compared to normal-appearing white matter, indicating that this imaging technique can help predict the spatial extent of brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D 1H MRSI of brain tumors at 3.0 Tesla using an eight-channel phased-array head coil. Osorio, JA., Ozturk-Isik, E., Xu, D., et al.[2013]

The novel convolutional encoder-model decoder (CEMD) architecture enables rapid and accurate spectral fitting for volumetric magnetic resonance spectroscopic imaging (MRSI) in patients with glioblastoma, processing whole-brain data in just 1 minute on a standard computer.

This deep learning approach combines traditional spectral models with advanced neural networks, significantly reducing processing time and improving the feasibility of using MRSI in routine clinical practice for monitoring brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporation of a spectral model in a convolutional neural network for accelerated spectral fitting. Gurbani, SS., Sheriff, S., Maudsley, AA., et al.[2023]

Magnetic resonance spectroscopy (MRS) enhances conventional MRI by providing quantitative analysis of brain metabolites, which can improve the diagnosis and management of brain tumors.

MRS has potential applications in differentiating between types of brain tumors, assessing tumor infiltration, and distinguishing between tumor and post-treatment changes, indicating its growing importance in neuro-oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance spectroscopy in gliomas]. Galanaud, D., Chinot, O., Metellus, P., et al.[2015]

Magnetic resonance spectroscopic imaging (MRSI) is a powerful non-invasive technique that provides detailed metabolic information about brain tumors, helping to identify key metabolites like N-acetylaspartate and choline, which indicate neuronal viability and membrane turnover, respectively.

MRSI enhances traditional MRI by allowing for the differentiation between neoplastic and non-neoplastic lesions, identifying tumor types, and assessing tumor heterogeneity, which can inform treatment decisions and monitor therapy side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton magnetic resonance spectroscopy imaging in the study of human brain cancer. Martínez-Bisbal, MC., Celda, B.[2013]

Multi-slice proton magnetic resonance spectroscopic imaging (MRSI) effectively evaluates brain metabolism and can identify changes in metabolites like NAA, Cr, and Cho in various cerebral disorders, including infarction and tumors.

In healthy individuals, Cr and Cho showed high intensity in the cerebellum, while in cases of cerebral infarction and brain tumors, NAA signals were absent, indicating neuronal loss, while Cr and Cho signals suggested gliosis or tumor growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mapping of cerebral metabolism on cerebral disorders using multi-slice proton magnetic resonance spectroscopic imaging]. Tanaka, C., Ebisu, T., Umeda, M., et al.[2015]

In a study of 78 patients suspected of having brain tumors, MR spectroscopy positively influenced treatment decisions in 16% of patients with positive findings and 52% of those with negative findings.

Only 3% of patients experienced a potential negative influence from MR spectroscopy, suggesting it is generally beneficial in managing suspected brain tumors, although further prospective studies are needed to confirm its impact on clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal brain lesions: effect of single-voxel proton MR spectroscopic findings on treatment decisions. Adamson, AJ., Rand, SD., Prost, RW., et al.[2015]

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