Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI

• Sponsor: Theranano LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03266848
• Collaborator: Massachusetts General Hospital (Other), Northeastern University (Other), National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 15
• Location: 1
• Actual Duration (Months): 32.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Disorders	Diagnostic Test: Quantitative Magnetic Resonance Imaging

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 Design

• Study Type: Observational
• Actual Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI
• Actual Study Start Date: Nov 8, 2017
• Actual Primary Completion Date: Jul 22, 2020
• Actual Study Completion Date: Jul 22, 2020

Outcome Measures

Primary Outcome Measures

1. Cerebrovascular Angiography [0-4 hours after ferumoxytol infusion]

   Obtain angiograms of the cerebral vasculature from the MRI intensity data

Secondary Outcome Measures

1. Quantitative cerebral blood volume atlas [0-4 hours after ferumoxytol infusion]

   Create cerebral blood volume atlas from the quantitative MRI intensity data

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Theranano LLC
• Massachusetts General Hospital
• Northeastern University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Srinivas Sridhar, Ph.D., Theranano LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Theranano LLC
• ClinicalTrials.gov Identifier: NCT03266848
• Other Study ID Numbers: R41DA043974; R41DA043974
• First Posted: Aug 30, 2017
• Last Update Posted: Aug 24, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Theranano LLC: Magnetic Resonance Imaging; Ferumoxytol
• Additional relevant MeSH terms: Cerebrovascular Disorders

Study Results

No Results Posted as of Aug 24, 2021