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

Trial Summary

What is the purpose of this trial?

To learn if MRS can effectively assess spinal cord lesions.

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 data supports the effectiveness of the treatment MRS Scan for Spinal Cord Lesions?

Research shows that magnetic resonance spectroscopy (MRS) can provide valuable biochemical information about spinal cord lesions, which may help predict and improve patient outcomes, as seen in studies involving conditions like cervical spondylotic myelopathy and spinal cord injury. ^{1 2 3 4 5}

Is the MRS scan for spinal cord lesions safe for humans?

MRS scans, including those for the spinal cord, are generally considered safe as they are non-invasive and have been used in studies with healthy volunteers and patients with conditions like multiple sclerosis without reported safety issues. ^{1 6 7 8 9}

How is the MRS Scan treatment different from other treatments for spinal cord lesions?

The MRS Scan is unique because it is a non-invasive technique that provides detailed information about the metabolism and biochemistry of spinal cord tissues, which is rarely done due to technical challenges. Unlike other treatments that focus on structural imaging, MRS offers insights into the biochemical changes in the spinal cord, potentially aiding in the diagnosis and management of conditions like multiple sclerosis and cervical spondylotic myelopathy. ^{2 5 6 8 9}

Research Team

Rami Eldaya, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

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

Metabolic Imaging Using Proton Magnetic Spectroscopy as a Predictor of Outcome After Surgery for Cervical Spondylotic Myelopathy. [2022]

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

Quantitative magnetic resonance spectroscopy in the entire human cervical spinal cord and beyond at 3T. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

3T proton MR Spectroscopy evaluation of spinal cord lesions. [2022]

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

Glutathione in the Pons Is Associated With Clinical Status Improvements in Subacute Spinal Cord Injury. [2023]

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

Proton magnetic resonance spectroscopy to evaluate spinal cord axonal injury in cervical spondylotic myelopathy. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

In vivo 1H-magnetic resonance spectroscopy of the spinal cord in humans. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

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

8. Poland pubmed.ncbi.nlm.nih.gov

Evaluation of 3T proton MR spectroscopy in the spinal cord - preliminary results. [2022]

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

Quantitative cervical spinal cord 3T proton MR spectroscopy in multiple sclerosis. [2022]