Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI
1 other identifier
observational
15
1 country
1
Brief Summary
This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the method with first-in-human studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
November 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2020
CompletedAugust 24, 2021
August 1, 2021
2.7 years
August 16, 2017
August 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cerebrovascular Angiography
Obtain angiograms of the cerebral vasculature from the MRI intensity data
0-4 hours after ferumoxytol infusion
Secondary Outcomes (1)
Quantitative cerebral blood volume atlas
0-4 hours after ferumoxytol infusion
Interventions
Radiological diagnosis
Eligibility Criteria
Patients with iron deficiency anemia already scheduled to receive ferumoxytol infusion for iron replacement therapy.
You may qualify if:
- Between the ages of 18 to 80;
- Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Theranano LLClead
- Massachusetts General Hospitalcollaborator
- Northeastern Universitycollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Timms L, Zhou T, Qiao J, Gharagouzloo C, Mishra V, Lahoud RM, Chen JW, Harisinghani M, Sridhar S. Super High Contrast USPIO-Enhanced Cerebrovascular Angiography Using Ultrashort Time-to-Echo MRI. Int J Biomed Imaging. 2024 Apr 13;2024:9763364. doi: 10.1155/2024/9763364. eCollection 2024.
PMID: 38644981DERIVED
Biospecimen
Subject blood sample before each scan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Srinivas Sridhar, Ph.D.
Theranano LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2017
First Posted
August 30, 2017
Study Start
November 8, 2017
Primary Completion
July 22, 2020
Study Completion
July 22, 2020
Last Updated
August 24, 2021
Record last verified: 2021-08