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Recruiting

NCT Number: NCT06548776

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

To learn if MRS can effectively assess spinal cord lesions.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD Anderson Cancer Center

Houston, Texas, 77090, United States

Location status: Recruiting

Location contact

Rami Eldaya, MD

CONTACT

[email protected]

713-745-2945

About this study

Primary Objective:

Establish the feasibility and spectrum of MRS for adult patients while mapping the total spine spectrum at short 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 low volume LMD receiving 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 low volume LMD to receive treatment CNS radiation:

  • Adults > 18 years old.
  • MR or CSF with evidence of LMD.
  • Patients to receive CSI as part of standard treatment of LMD disease.
  • Consent able patients, willingness and ability to comply with the study procedures.
  • No spinal cord lesions only LMD disease
  • Recruitment by radiation oncology faculty in consultation with Dr. De. . .

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 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.

Treatment and study plan

Magnetic Resonance Spectroscopy (MRS) Scan

Diagnostic Test

Participants will receive MRS Scan

Primary outcomes

  1. Safety and Adverse Events (AEs)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Rami Eldaya, MD

CONTACT

[email protected]

(713) 745-2945

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Aug 12, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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