NCT06548776

Brief Summary

To learn if MRS can effectively assess spinal cord lesions.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
28mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Sep 2024Jul 2028

First Submitted

Initial submission to the registry

August 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

September 4, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

August 8, 2024

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

    Through study completion; an average of 1 year.

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

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

Diagnostic Test: Magnetic Resonance Spectroscopy (MRS) Scan

Patients

EXPERIMENTAL

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

Diagnostic Test: Magnetic Resonance Spectroscopy (MRS) Scan

Interventions

Participants will receive MRS Scan

Healthy VolunteersPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. . .

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77090, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Positron-Emission TomographyRadionuclide Imaging

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Rami Eldaya, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 12, 2024

Study Start

September 4, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2028

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations