RECRUITING

Positron Emission Tomography (PET) Imaging of Thrombosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to evaluate a new radiotracer called 64Cu-FBP8 for PET-MR imaging of thrombosis. The tracer has the potential of detecting thrombosis anywhere in the body, for instance in the left atrial appendage of patients with atrial fibrillation, and thereby may provide a non-invasive alternative to the current standard-of-care methods.

Official Title

Preliminary Evaluation of [64Cu]FBP8 in Healthy Individuals and Subjects With Known or at Risk of Developing Thrombosis

Quick Facts

Study Start:2016-04-01
Study Completion:2026-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03830320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Subjects less than 18 years of age;
  2. * Electrical implants such as cardiac pacemaker or perfusion pump;
  3. * Pregnant or breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate);
  4. * Claustrophobic reactions;
  5. * Subjects will be excluded if research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
  6. * Unable to lie comfortably on a bed inside the PET scanner;
  7. * Subjects under direct or indirect (i.e. same department as PIs) supervision of the principal investigator;
  8. * Body weight over the weight limit for the moving table (\> 300 lbs for the MRI table and \>441 lbs for the CT table);
  9. * Metallic or electric implants contraindicated for MR-PET scanning when applicable;
  10. * Does not have the ability to give written informed consent.
  11. * Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures);
  12. * Stroke within the last 3 months;
  13. * Myocardial infarction within the last 3 months;
  14. * Cardiac or major surgery within the last 3 months;
  15. * History of chest pain within the last 6 weeks unless followed by a subsequent stress test or coronary angiography;
  16. * History of syncope within the last 6 weeks;
  17. * Heart rate persistently \>120 bpm or persistently \< 50 bpm;
  18. * Presence of daytime pauses \> 3s

Contacts and Locations

Study Contact

David E Sosnovik, MD
CONTACT
617-724-3407
sosnovik@nmr.mgh.harvard.edu
Anne L Philip, MPH
CONTACT
617-726-0431
alphilip@mgh.harvard.edu

Principal Investigator

Ciprian Catana, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Ciprian Catana, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-04-01
Study Completion Date2026-01-30

Study Record Updates

Study Start Date2016-04-01
Study Completion Date2026-01-30

Terms related to this study

Keywords Provided by Researchers

  • PET-MRI

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • COVID-19
  • Cancer
  • Thrombosis