Status:
COMPLETED
Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI
Lead Sponsor:
Theranano LLC
Collaborating Sponsors:
Massachusetts General Hospital
Northeastern University
Conditions:
Cerebrovascular Disorders
Eligibility:
All Genders
18-80 years
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 schedul...
Eligibility Criteria
Inclusion
- Between the ages of 18 to 80;
- Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures.
Exclusion
- 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.
Key Trial Info
Start Date :
November 8 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 22 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03266848
Start Date
November 8 2017
End Date
July 22 2020
Last Update
August 24 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114