- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06548776
Establishing Daily Applicable Parameters for Using Magnetic Resonance Spectroscopy of Spinal Cord
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77090
- MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy Volunteers
Participants will be recruited from DI volunteer pool to implement MRS spine on.
|
Participants will receive MRS Scan
|
|
Experimental: Patients
Participants will be recruited from DI volunteer pool to implement MRS spine on.
|
Participants will receive MRS Scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Through study completion; an average of 1 year.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rami Eldaya, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0249
- NCI-2024-06761 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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