Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI

Theranano

Status: Completed

Conditions: Cerebrovascular Disorders

Treatments: Diagnostic Test: Quantitative Magnetic Resonance Imaging

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT03266848

R41DA043974 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the method with first-in-human studies.

Full description

This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI using Ferumoxytol as a contrast agent, and validate the method with first-in-human studies. Subjects who are already scheduled to receive ferumoxytol infusion will undergo MRI scans after the infusion. The ferumoxytol infusion itself is not a part of the study. The project will provide brain angiograms and establish a human cerebrovascular atlas that will enable future quantitative diagnosis of cerebrovascular abnormalities by revealing abnormal regions of the brain that characterize disease, a tool which doesn't currently exist, and which could lead to many exciting discoveries and clinical applications in neurology.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between the ages of 18 to 80;
• Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures.

Exclusion criteria

• Known allergy to ferumoxytol or any intravenous iron preparation;
• Iron saturation above the upper limit of normal;
• Individuals with a contraindication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator);
• Individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease;
• Individuals with any serious medical condition that the investigator believes may place them at increased risk for an adverse event.