Spinal CordNCT06548776
Establishing Daily Applicable Parameters for Using Magnetic Resonance Spectroscopy of Spinal Cord
A study testing Magnetic Resonance Spectroscopy (MRS) Scan in people with Spinal Cord, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if MRS can effectively assess spinal cord lesions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord
- What is being tested?
- Magnetic Resonance Spectroscopy (MRS) Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 25 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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. . .
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To learn if MRS can effectively assess spinal cord lesions.
Read the 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.
- Conditions
- Spinal Cord
- Being tested
- Magnetic Resonance Spectroscopy (MRS) Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Spectroscopy (MRS) ScanDiagnostic test
Participants will receive MRS Scan
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Participants will be recruited from DI volunteer pool to implement MRS spine on. Receives: Diagnostic Test: Magnetic Resonance Spectroscopy (MRS) Scan |
| Patients | Experimental | Participants will be recruited from DI volunteer pool to implement MRS spine on. Receives: Diagnostic Test: Magnetic Resonance Spectroscopy (MRS) Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start4 Sep 2024
- Primary completion25 Aug 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal CordStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rami Eldaya, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548776
- Sponsor's protocol ID
- 2024-0249
- Other IDs
- NCI-2024-06761
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No