pH-weighted MRI in Multiple Sclerosis: A Surrogate Marker of Tissue Metabolic Stress

NCT ID: NCT03028675

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-08-10

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Multiple Sclerosis

MRI Scan

Intervention Type: OTHER

MRI scans will consist of a 1-hour brain scan for both patients and controls.

Healthy Volunteer

10 age-matched control volunteers

MRI Scan

Intervention Type: OTHER

MRI scans will consist of a 1-hour brain scan for both patients and controls.

Interventions

MRI Scan

MRI scans will consist of a 1-hour brain scan for both patients and controls.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yulin Ge, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

16-01434

Identifier Type: -

Identifier Source: org_study_id