PET Fibrin Imaging of DVT and PE

Launched by PETER CARAVAN · Jul 15, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique using a special PET scan to help doctors identify fresh blood clots in patients with pulmonary embolism (PE) and deep vein thrombosis (DVT). These conditions occur when blood clots form in the veins, which can lead to serious health issues. The goal is to improve the ability to see and diagnose these clots, potentially leading to better treatment options.

To participate in this study, individuals must be at least 18 years old and have a confirmed case of pulmonary embolism shown by a specific type of imaging test called CT angiography. Participants will need to receive the imaging agent within 72 hours of their diagnosis. Those who are pregnant, breastfeeding, or have certain health conditions may not be eligible. If accepted into the study, participants can expect to undergo a PET scan, which may provide valuable information for their treatment. It's important to note that this study is actively recruiting participants and aims to improve the ways we can detect and manage blood clots.

Gender

ALL

Eligibility criteria

• 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 risk
• • Hemodynamic instability, including requiring escalating doses of vasopressor medication.
• • 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.