- 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 (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rami Eldaya, MD
- Phone Number: (713) 745-2945
- Email: reldaya@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77090
- Recruiting
- Md Anderson Cancer Center
-
Contact:
- Rami Eldaya, MD
- Phone Number: 713-745-2945
- Email: reldaya@mdanderson.org
-
-
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 (Estimated)
Study Completion (Estimated)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord
-
Ecole Polytechnique Fédérale de LausanneRecruitingChronic Spinal Cord Injury | Spinal Cord Injury (SCI) | Spinal Cord Injury | SCI - Spinal Cord Injury | SCI | Subacute Spinal Cord InjurySwitzerland
-
Lian-Cing Yan, MSPTNot yet recruitingSpinal Cord Injury | Spinal Cord Stimulation | Spinal Cord Injury/Damage | Spinal Cord Injury Thoracic | Spinal Cord Stimulation (SCS) | Spinal Cord Injury T1-L2 | Epidural Electrical StimulationTaiwan
-
The University of Texas Health Science Center,...TerminatedSpinal Cord Injuries | Cervical Spinal Cord Injury | Traumatic Spinal Cord CompressionUnited States
-
Institut GuttmannNot yet recruitingSpinal Cord Injury | Spinal Cord Disease | Spinal Cord Injuries (SCI) | Traumatic Spinal Cord InjuriesSpain
-
Jill M. Wecht, Ed.D.Icahn School of Medicine at Mount SinaiRecruitingBlood Pressure | Spinal Cord Injuries | SCI - Spinal Cord Injury | Blood Pressure Disorders | Traumatic Spinal Cord Injury | Acute Spinal Cord Injury | Neuromodulation | Spinal Cord StimulationUnited States
-
Kessler FoundationNot yet recruitingSpinal Cord Injury | Spinal Cord Disease | Spinal Cord Injuries (SCI)United States
-
Taipei Veterans General Hospital, TaiwanThe Industrial Technology Research InstituteUnknownSpinal Cord Injuries | Complete Spinal Cord Injury | Incomplete Spinal Cord InjuryTaiwan
-
Chang Gung Memorial HospitalNot yet recruitingSpine Injury | Complete Spinal Cord Injury | Incomplete Spinal Cord Injury | Cord Injury, Spinal | Cord Infarction Spinal
-
University of California, San FranciscoUnited States Department of Defense; Congressionally Directed Medical Research...Enrolling by invitationSpinal Cord Injury, Acute | Spinal Cord Injury Cervical | Spinal Cord Injury (SCI), Initial EncounterUnited States
-
University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedSCI - Spinal Cord Injury | Incomplete Spinal Cord InjuryUnited States
Clinical Trials on Magnetic Resonance Spectroscopy (MRS) Scan
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Completed
-
Mclean HospitalWithdrawnSchizophrenia | Bipolar Disorder | Healthy ControlsUnited States
-
Centre Hospitalier Universitaire, AmiensActive, not recruitingCovid19 | Brain Damage | Neurological ManifestationsFrance
-
Weill Medical College of Cornell UniversityEisai Inc.WithdrawnGlioblastoma Multiforme | Anaplastic Astrocytoma | Anaplastic OligodendrogliomaUnited States
-
M.D. Anderson Cancer CenterCompleted
-
Loma Linda UniversityTerminated
-
National Taiwan University HospitalCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
Assistance Publique Hopitaux De MarseilleUnknown
-
Assistance Publique Hopitaux De MarseilleUnknownChildren Born Very Prematurely in Relation to Structural Brain Abnormalities