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Completed

NCT Number: NCT03266848

Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quantitative Magnetic Resonance Imaging

Diagnostic Test

Radiological diagnosis

Primary outcomes

  1. Cerebrovascular Angiography

    Time frame: 0-4 hours after ferumoxytol infusion

    Obtain angiograms of the cerebral vasculature from the MRI intensity data

Secondary outcomes

  1. Quantitative cerebral blood volume atlas

    Time frame: 0-4 hours after ferumoxytol infusion

    Create cerebral blood volume atlas from the quantitative MRI intensity data

Sponsors and collaborators

Lead sponsor

Theranano LLC

Industry

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2017
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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