Last updated: December 5, 2023
Sponsor: Peter Caravan
Overall Status: Active - Recruiting
Phase
1
Condition
Venous Thromboembolism
Chest Pain
Claudication
Treatment
64Cu-FBP8
PET-CT imaging
Clinical Study ID
NCT04022915
2018P000523
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 years of age or older with a clinically significant pulmonary embolus (PE)confirmed by a filling defect in CT angiography (CTA), and
- Subjects must receive the radiotracer injection within 72 hours of their diagnosis.
Exclusion
Exclusion Criteria:
- Subjects < 18 years of age
- Time of expected radiotracer injection > 72 hours from the time of a positive venousduplex ultrasound or CT- angiogram
- Women subjects of childbearing potential who are pregnant, seeking to become pregnant,or have a positive serum pregnancy (beta-HCG) test
- Unable to lie flat for 45 minutes as assessed by physical examination and medicalhistory (e.g. back pain, arthritis, dyspnea),
- Weight that exceeds the PET camera table limit (300 kg)
- The subject will not be enrolled in the study if the radiation exposure for researchstudies during the prior 12 months, combined with the exposure from this study wouldexceed 50 mSv (millisievert).
- Due to the radiation exposure from imaging studies, all women of childbearingpotential will be required to have a negative serum pregnancy test performed prior toany imaging procedures on the same day (if not already done that day). Patients with apositive serum pregnancy test will be excluded. Breast feeding women will also beexcluded.
- A pre-existing condition or use of a medication including vasopressors and tPA (tissuePlasminogen Activator) that in the opinion of the investigator may place the subjectat a substantially increased risk
- Hemodynamic instability, including requiring escalating doses of vasopressormedication.
- No groups designated as "special vulnerable populations" will be studied.
- No exclusions will be made based on race, sex, or ethnic origin.
- 64Cu-FBP8 (Copper-64 labeled fibrin binding probe 8) is cleared by the kidneys,patients with eGFR (estimated Glomerular Filtration Rate ) < 30 will be excluded.
Study Design
Total Participants: 80
Treatment Group(s): 2
Primary Treatment: 64Cu-FBP8
Phase: 1
Study Start date:
May 13, 2019
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
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