PET Fibrin Imaging of DVT and PE

NCT ID: NCT04022915

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-13
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Acute pulmonary embolism

Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging.

Group Type: EXPERIMENTAL

64Cu-FBP8

Intervention Type: DRUG

Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject.

PET-CT imaging

Intervention Type: DIAGNOSTIC_TEST

All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.

Interventions

64Cu-FBP8

Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject.

Intervention Type: DRUG

PET-CT imaging

All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Peter Caravan

OTHER

Sponsor Role: lead

Responsible Party

Peter Caravan

Associate Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tilo Winkler, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tilo Winkler, PhD

Role: CONTACT

Phone: 617-724-4083

Email: twinkler@mgh.harvard.edu

Mamary T Kone, MD, MPH

Role: CONTACT

Phone: 617-726-1082

Email: mkone@mgh.harvard.edu

Facility Contacts

Tilo Winkler, PhD

Role: primary

Other Identifiers

2018P000523

Identifier Type: -

Identifier Source: org_study_id