Skip to main content
OpenTrials
Completed

NCT Number: NCT03028675

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI scan

Other

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

Primary outcomes

  1. pH measurements

    Time frame: 20 Minutes

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2017
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.