Clinical trial NCT03028675: pH-weighted MRI in Multiple Sclerosis: A Surrogate Marker of Tissue Metabolic Stress
Official title: pH-weighted MRI in Multiple Sclerosis: A Surrogate Marker of Tissue Metabolic Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapse-remitting multiple sclerosis from NYU Langone Health and age-matched healthy volunteers recruiting using previous database of volunteers

Brief summary: Twenty subjects (10 patients and 10 age-matched control volunteers) will be recruited for this study. MRI scans will take place on a 3T MRI Scanner (Skyra or Prisma, Siemens Medical Solutions) located at The NYU Center for Biomedical Imaging. MRI scans will consist of a 1-hour brain scan for both patients and controls. In the first 6 months of the study, investigators will develop and test a uMT-based APT imaging for brain tissue pH measurement and use a hypercapnia paradigm to validate the tissue pH changes between breathing room air and 5% CO2 (by increasing tissue acidity) inhalation. With implementation of hypercapnia MRI, pH-weighted imaging will be validated for its robustness and reproducibility.

Detailed description: The contrast agent (Gd-DTPA, Gadavist) will be injected intravenously (IV) in the arm (patients only). The IV will be inserted by qualified medical professional at CBI. This contrast agent will be standard dose in accordance with its FDA approved labeling and dosing. Controls will NOT be administered the contrast agent.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female non-MS control volunteers

Exclusion Criteria:

* Medically unstable or with cardiac, pulmonary, hematological, renal, or hepatic dysfunction.
* Current or past DSM-IV diagnosis of major depression, bipolar and psychotic disorders.
* Contraindications for MRI, including
* Intracranial clips
* Metal implants
* External metallic devices/objects/clips within 10mm of the head
* Suspected or confirmed metal in the eyes (history of welding or similar activity)
* Claustrophobia
* Cardiac pacemaker or pacing wires
* Pregnancy - Pregnancy tests will be offered to women of childbearing age at no cost to the subject
* History of moderate to severe head injury, stroke, and seizures.
* Alcoholism or drug dependency.
* Renal or liver disease as this may cause concerns related to Gd-DTPA contrast agent.

  * Allergy to the contrast agent Gadolinium
  * Relapses or steroid therapy in patient at or in the month preceding the study
  * Patients only

Primary outcomes:
measure: pH measurements
timeFrame: 20 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Yulin Ge, MD
role: PRINCIPAL_INVESTIGATOR
References: