PET Fibrin Imaging of DVT and PE (NCT04022915) | Clinical Trial Compass
TerminatedPhase 1
PET Fibrin Imaging of DVT and PE
Stopped: The study did not reach its enrollment target due to a relatively narrow time window for imaging after the contrast CT imaging confirmed PE and limitations in the availability of the tracer and the PET scanner.
United States6 participantsStarted 2019-05-13
Plain-language summary
This study aims to investigate a novel positron emission tomography(PET)-probe for imaging of fresh intravascular blood clots in pulmonary embolism (PE) and deep venous thrombosis (DVT).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Criteria:
* Subjects \< 18 years of age
* Time of expected radiotracer injection \> 72 hours from the time of a positive venous duplex 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 medical history (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 research studies during the prior 12 months, combined with the exposure from this study would exceed 50 mSv (millisievert).
* Due to the radiation exposure from imaging studies, all women of childbearing potential will be required to have a negative serum pregnancy test performed prior to any imaging procedures on the same day (if not already done that day). Patients with a positive serum pregnancy test will be excluded. Breast feeding women will also be excluded.
* A pre-existing condition or use of a medication including vasopressors and tPA (tissue Plasminogen Activator) that in the opinion of the investigator may place the subject at a substantially increased r…
What they're measuring
1
Location of the Thrombus Within the Lungs
Timeframe: 72 hours
2
Location of Clot Burden Measurements Within the Thigh
Timeframe: 72 hours
3
Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity