Manganese-Enhanced Magnetic Resonance Imaging in Healthy Volunteers and People With Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2022
• Main ID: NCT01326715
• Date of registration: 30/03/2011
• Prospective Registration: Yes
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: Manganese-Enhanced Magnetic Resonance Imaging in Healthy Volunteers and People With Multiple Sclerosis
• Scientific title: Manganese-Enhanced Magnetic Resonance Imaging in Healthy Volunteers and People With Multiple Sclerosis
• Date of first enrolment: October 17, 2013
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01326715
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Daniel S Reich, M.D.
• Affiliation: National Institute of Neurological Disorders and Stroke (NINDS)

Key inclusion & exclusion criteria

- This study enrolls two cohorts:

- Up to 15 healthy volunteers

- Up to 15 MS patients

INCLUSION CRITERIA:

- Age 18 to 70 (inclusive)

- Able to give informed consent

- Able to comply with study procedures

- Diagnosis of multiple sclerosis according to the current McDonald Criteria

- Evidence of abnormal permeability of the brain or cerebrospinal fluid, based on a
screening gadolinium-enhacned MRI scancan

EXCLUSION CRITERIA:

- Reported history of clinically significant medical disorders, such as liver or kidney
disease, that could potentially increase the risk of CNS damage due to manganese
exposure

- Uncontrolled hypertension, demonstrated by a blood pressure reading of >160/100 at
screening on repeat exam

- Screening labs demonstrating any value for hepatic or biliary function out of the
range of normal, to include AST, ALT, bilirubin, gammaGT, alkaline phosphatase; repeat
value of the same test showing normal results will remove the exclusion

- For patients receiving ocular MRI, reported history of ocular disorders

- Previous or current alcohol and/or substance abuse

- Previous presumed occupational exposure to manganese (i.e., having worked in a mine,
foundry, smelter, dry cell battery manufacturing facility, or agriculture)

- Medical contraindications for MRI (e.g., any non-organic implant or other device such
as a cardiac pacemaker or infusion pump or other metallic implants, objects or body
piercings that are not MRI-safe or that cannot be removed)

- Psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the
time the medical history is collected

- Pregnancy or current breastfeeding

- Allergy to manganese

- Reported history of impaired hearing, because people with impaired hearing are at
increased risk of sound-induced damage from the MRI scanner

- Ongoing treatment with calcium-channel blockers

- Clinically significant iron-deficiency anemia

- 5 contrast-enhancing lesion on screening MRI performed within one week of
administration of mangafodipir



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Mangafodipir (Teslascan)

Primary Outcome(s)

The primary outcome measure is normalized T1-weighted signal intensity. [Time Frame: early time points after mangafodipir administration]

Secondary ID(s)

110116

11-N-0116

Source(s) of Monetary Support

Please refer to primary and secondary sponsors