Establishing Daily Applicable Parameters for Using Magnetic Resonance Spectroscopy of Spinal Cord

Not Applicable

Recruiting

• Conditions: Spinal Cord
• Interventions: Diagnostic Test: Magnetic Resonance Spectroscopy (MRS) Scan

• Registration Number: NCT06548776
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To learn if MRS can effectively assess spinal cord lesions.

Detailed Description

Primary Objective:

Establish the feasibility and spectrum of MRS for adult patients while mapping the total spine spectrum at different TEs to allow for future comparison with patients to assess spinal cord lesions malignant potential and grade.

Secondary Objective:

Test success of the spectrum by implementing the protocol on 3 patients with spinal LMD receiving CSI. This will allow us to test reproducibility of the protocol and test effect of radiation on spinal cord at different time frames. This will serve as secondary data for subsequent trials targeting functional statues after radiation and tumor grading predictability of MRS.

Study Timeline

• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-12
• Study Start: 2024-09-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Volunteers:

• Adults > 18 years
• Healthy with no malignancy, demyelinating disease, back pain, degenerative disease, or spinal cord lesions.
• Consent able patients.

Patients with high risk for LMD to receive prophylactic CNS radiation:

• Adults > 18 years old.
• MR or CSF without evidence of LMD.
• Patients with high risk for LMD to receive CSI as part of standard treatment of prophylactic LMD disease.
• Consent able patients, willingness and ability to comply with the study procedures.
• No spinal cord lesions.

Exclusion Criteria

Volunteers:

• Age < 18 years
• Pregnant or breastfeeding individuals.
• History of cancer.
• History of spinal cord lesions including malignant, demyelinating, or inflammatory.
• History of prior spinal surgery.
• History of implantable devices.
• History of MR claustrophobia.
• Degenerative disease or spinal/back pain including myelopathy and radiculopathy.
• Scoliosis.

Patients with high risk for spinal LMD:

• Age < 18 years
• History of spinal cord lesions including malignant, demyelinating, or inflammatory.
• History of prior spinal surgery.
• History of implantable devices.
• History of MR claustrophobia.
• Degenerative disease or spinal/back pain including myelopathy and radiculopathy.
• Scoliosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Magnetic Resonance Spectroscopy (MRS) Scan	Participants will be recruited from DI volunteer pool to implement MRS spine on.
Patients	Magnetic Resonance Spectroscopy (MRS) Scan	Participants will be recruited from DI volunteer pool to implement MRS spine on.

Primary Outcome Measures

Name	Time	Method
Safety and Adverse Events (AEs)	Through study completion; an average of 1 year.	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States