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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03028675
Enrollment
4
Registered
2017-01-23
Start date
2017-05-01
Completion date
2018-08-10
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

OTHERMRI Scan

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

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pH measurements20 MinutesThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026