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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028675
• Other study ID #: 16-01434
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: August 10, 2018

Study information

• Verified date: July 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pH measurements	The pH will be estimated based on the calibration methods of quantification of exchange as a function of saturation time (QUEST)32 and its ratiometric analysis (QUESTRA) 33.	20 Minutes