pH-weighted MRI in Multiple Sclerosis: A Surrogate Marker... | NCT03028675

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

NCT03028675

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Jul 13, 2020Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

MRI Scan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

Aug 10, 2018Actual

Completion Date

Aug 10, 2018Actual

First Submitted Date

Jan 19, 2017

First Submission Date that Met QC Criteria

Jan 19, 2017

First Posted Date

Jan 23, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2020

Last Update Posted Date

Jul 13, 2020Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multiple Sclerosis			Other: MRI Scan
Healthy Volunteer		10 age-matched control volunteers	Other: MRI Scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI Scan	Other	MRI scans will consist of a 1-hour brain scan for both patients and controls.	Healthy Volunteer Multiple Sclerosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with relapse-remitting multiple sclerosis from NYU Langone Health and age-matched healthy volunteers recruiting using previous database of volunteers

Sampling Method

Non-Probability Sample

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques