MRS Scan for Spinal Cord Lesions

Overseen By Rami Eldaya, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cancer, Spinal lesions, Surgery, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Magnetic Resonance Spectroscopy (MRS), a special type of MRI, can effectively examine spinal cord lesions. It includes two groups: healthy volunteers and patients with leptomeningeal disease (LMD), a condition affecting the central nervous system. Healthy volunteers should not have spinal issues such as back pain or previous surgeries, while patients should have LMD but no spinal cord lesions. The goal is to assess whether MRS can serve as a useful tool for evaluating spinal health. As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance diagnostic techniques for spinal health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this MRS scan is safe for assessing spinal cord lesions?

Research has shown that Magnetic Resonance Spectroscopy (MRS) scans are generally safe. Studies have found that MRS scans provide more detailed information about the spinal cord than regular scans. They function like a more advanced MRI, helping doctors better understand the spine's internal conditions.

MRS is non-invasive, meaning it doesn't involve surgery or entering the body. No specific reports of serious side effects from MRS use exist, suggesting most people tolerate the procedure well. MRI-based techniques like MRS have been used safely for many years because they do not use radiation.

For those considering joining a trial involving MRS, these findings suggest that the procedure is safe and generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Magnetic Resonance Spectroscopy (MRS) scan for spinal cord lesions because it offers a unique way to analyze the biochemical changes in the spinal cord non-invasively. Unlike traditional MRI scans that provide structural images, MRS can detect metabolic changes, potentially allowing for earlier and more precise diagnosis of spinal cord abnormalities. This technique could lead to better understanding and monitoring of spinal cord conditions, which may improve treatment outcomes in the long run.

What evidence suggests that MRS is effective for assessing spinal cord lesions?

Studies have shown that Magnetic Resonance Spectroscopy (MRS) effectively assesses changes in spinal cord lesions. MRS provides detailed information about tissue chemistry, aiding in understanding the condition of these lesions. Research indicates that MRS is non-invasive and can detect chemical changes that regular MRI scans might miss. Although results can vary, MRS has been linked to better outcomes in some cases of spinal cord injury. Overall, MRS is considered a promising tool for evaluating spinal cord health. Participants in this trial will undergo MRS scans to further explore its effectiveness in assessing spinal cord lesions. ^{1 3 4 6 7}

Who Is on the Research Team?

Rami Eldaya, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 without spinal cord lesions, prior spinal surgery, implantable devices, MR claustrophobia, or degenerative back conditions. It includes those at high risk for LMD needing CNS radiation and healthy volunteers with no history of cancer or demyelinating diseases.

Exclusion Criteria

I am under 18 or have a history of spinal issues, surgery, implants, MRI claustrophobia, or back pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implementation of Magnetic Resonance Spectroscopy (MRS) on the spinal cord to assess lesions

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Resonance Spectroscopy (MRS) Scan

Trial Overview

The trial is testing the use of Magnetic Resonance Spectroscopy (MRS) to evaluate the spinal cord in patients at risk for leptomeningeal disease (LMD) and in healthy individuals to establish daily applicable parameters.

How Is the Trial Designed?

Group I: Patients Experimental Treatment 1 Intervention

Participants will be recruited from DI volunteer pool to implement MRS spine on.

Group II: Healthy Volunteers Experimental Treatment 1 Intervention

Participants will be recruited from DI volunteer pool to implement MRS spine on.

Magnetic Resonance Spectroscopy (MRS) Scan is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Magnetic Resonance Spectroscopy Scan for:

• Diagnostic imaging of spinal cord lesions
• Characterization of spinal cord tumors
• Differentiation of benign from malignant lesions

Approved in United States as Magnetic Resonance Spectroscopy Scan for:

• Diagnostic imaging of spinal cord lesions
• Characterization of spinal cord tumors
• Differentiation of benign from malignant lesions

Approved in Canada as Magnetic Resonance Spectroscopy Scan for:

• Diagnostic imaging of spinal cord lesions
• Characterization of spinal cord tumors
• Differentiation of benign from malignant lesions

Approved in Japan as Magnetic Resonance Spectroscopy Scan for:

• Diagnostic imaging of spinal cord lesions
• Characterization of spinal cord tumors
• Differentiation of benign from malignant lesions

Approved in China as Magnetic Resonance Spectroscopy Scan for:

• Diagnostic imaging of spinal cord lesions
• Characterization of spinal cord tumors
• Differentiation of benign from malignant lesions

Approved in Switzerland as Magnetic Resonance Spectroscopy Scan for:

• Diagnostic imaging of spinal cord lesions
• Characterization of spinal cord tumors
• Differentiation of benign from malignant lesions

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Using 3T (1)H-MR spectroscopy, researchers measured metabolite levels in the cervical spinal cord of 15 patients with relapsing-remitting multiple sclerosis (RRMS) and found significant biochemical changes compared to healthy individuals, indicating neuronal damage.

The study revealed a decrease in the N-acetylaspartate/choline ratio and an increase in choline/creatine and myo-inositol/creatine ratios in MS plaques, suggesting that (1)H-MR spectroscopy can effectively assess spinal cord integrity and may help monitor disease progression in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative cervical spinal cord 3T proton MR spectroscopy in multiple sclerosis. Marliani, AF., Clementi, V., Albini Riccioli, L., et al.[2022]

An improved magnetic resonance spectroscopy (MRS) protocol allows for better diagnostic imaging of the entire cervical spine, overcoming previous technical challenges like magnetic field inhomogeneities and cerebrospinal fluid flow.

Validation in healthy volunteers and patients with conditions like multiple sclerosis shows that this enhanced MRS technique provides high-quality spectral data, highlighting its potential for diagnosing spinal cord pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative magnetic resonance spectroscopy in the entire human cervical spinal cord and beyond at 3T. Henning, A., Schär, M., Kollias, SS., et al.[2022]

In a study involving 18 subjects with traumatic spinal cord injury (SCI) and 20 healthy controls, researchers found that higher levels of glutathione in the pons were associated with improved motor scores during rehabilitation, suggesting a potential biomarker for recovery.

The study also revealed changes in metabolic levels, such as increased N-acetylaspartate and glutamate/glutamine in complete SCI, and decreased creatine in incomplete paraplegic SCI, indicating distinct biochemical alterations related to the severity of the injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glutathione in the Pons Is Associated With Clinical Status Improvements in Subacute Spinal Cord Injury. Wyss, PO., Richter, JK., Zweers, P., et al.[2023]

Magnetic resonance spectroscopy (MRS) can effectively assess spinal cord biochemistry in patients with cervical spondylotic myelopathy (CSM), revealing significant differences compared to healthy controls.

Patients with CSM showed a significantly lower N-acetylaspartate (NAA)/creatine (Cr) ratio, indicating potential axonal and neuronal loss, and one-third of patients exhibited lactate peaks, suggesting ischemia may play a role in CSM pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton magnetic resonance spectroscopy to evaluate spinal cord axonal injury in cervical spondylotic myelopathy. Holly, LT., Freitas, B., McArthur, DL., et al.[2022]

A new 1H-magnetic resonance spectroscopy (1H-MRS) protocol was developed for examining intramedullary lesions in the spinal cord, demonstrating its potential for providing valuable diagnostic information.

In a study involving healthy volunteers, nearly 60% of the acquired spectra were of acceptable quality, indicating that while there are challenges with small voxel sizes, the technique can still be effectively applied to spinal cord examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of 3T proton MR spectroscopy in the spinal cord - preliminary results. Wawrzyniak, P., Hebda, A., Heinze, S., et al.[2022]

This study introduces the use of magnetic resonance spectroscopy (MRS) to analyze the cervical spinal cord, a technique that has not been previously reported, expanding the application of MRS beyond the brain.

The research highlights current limitations of this technique while also discussing potential technological improvements and future applications, indicating a promising avenue for studying central nervous system conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo 1H-magnetic resonance spectroscopy of the spinal cord in humans. Gómez-Ansón, B., MacManus, DG., Parker, GJ., et al.[2022]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[2022]

Magnetic resonance spectroscopy (MRS) can effectively quantify metabolic changes in the spinal cord of patients with cervical spondylotic myelopathy (CSM) and predict surgical outcomes, as shown in a study of 16 patients with a follow-up of 19 months.

The ratios of N-acetyl-aspartate (NAA) to creatine (Cr) and choline (Cho) to NAA were significantly correlated with improvements in neurological function after surgery, indicating that these metabolic markers can help assess the effectiveness of surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Imaging Using Proton Magnetic Spectroscopy as a Predictor of Outcome After Surgery for Cervical Spondylotic Myelopathy. Holly, LT., Ellingson, BM., Salamon, N.[2022]

In a study of 50 patients with intramedullary spinal cord lesions, magnetic resonance spectroscopy (MRS) significantly improved detection rates from 58% with conventional MRI to 84%, highlighting its efficacy in identifying lesions.

MRS provides valuable additional information that can help differentiate between benign and malignant spinal cord tumors, potentially reducing the need for unnecessary biopsies and surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3T proton MR Spectroscopy evaluation of spinal cord lesions. Sathyanathan, BP., Raju, BP., Natarajan, K., et al.[2022]

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