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Recruiting NCT06548776

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

No phase Interventional Spinal Cord

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Spectroscopy (MRS) Scan.
Who it may be relevant to
Registry conditions: Spinal Cord. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 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.

Interventions

  • Diagnostic test Magnetic Resonance Spectroscopy (MRS) Scan
    Participants will receive MRS Scan

Primary outcome measures

  • Safety and Adverse Events (AEs) [Time frame: Through study completion; an average of 1 year.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT06548776 · 2024-0249 · NCI-2024-06761

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗