Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI

Completed

• Conditions: Cerebrovascular Disorders

• Registration Number: NCT03266848
• Lead Sponsor: Theranano LLC

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-30
• Study Start: 2017-11-08
• Primary Completion: 2020-07-22
• Study Completion: 2020-07-22
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cerebrovascular Angiography	0-4 hours after ferumoxytol infusion	Obtain angiograms of the cerebral vasculature from the MRI intensity data

Secondary Outcome Measures

Name	Time	Method
Quantitative cerebral blood volume atlas	0-4 hours after ferumoxytol infusion	Create cerebral blood volume atlas from the quantitative MRI intensity data

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States