NCT04022915

PET Fibrin Imaging of DVT and PE

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Peter Caravan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Venous thromboembolism (VTE) is one of the most common causes of death in the United States, resulting in more than 100,000 deaths annually. Current diagnostic techniques rely on indirect measures of clot for diagnosis and therefore suffer from the problems of both under and overdiagnosis and cannot always be performed on patients with renal failure and lung disease. In this study, we will use the novel fibrin-specific probe 64CU-FBP8 (Copper-64 labeled fibrin binding probe 8) for PET imaging of fresh blood clots in PE and DVT. Our long-term goal is to establish a novel thrombus body scan (TBS) using 64CU-FBP8 for PET imaging to overcome the limitations of indirect venous thromboembolism diagnosis, and, with one single test, provide a total-body assessment of fresh intravascular clot.

Conditions

• Pulmonary Embolism
• Deep Vein Thrombosis
• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	64Cu-FBP8	Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject.
DIAGNOSTIC_TEST	PET-CT imaging	All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.

Timeline

• Start date: 2019-05-13
• Primary completion: 2022-07-19
• Completion: 2024-08-26
• First posted: 2019-07-17
• Last updated: 2026-03-18
• Results posted: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study