PET Fibrin Imaging of DVT and PE

Pulmonary Embolism Clinical Trial

Official title:

PET Fibrin Imaging of DVT and PE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04022915
• Other study ID #: 2018P000523
• Status: Recruiting
• Phase: Phase 1
• Start date: May 13, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Tilo Winkler, PhD
• Phone: 617-724-4083
• Email: twinkler[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Peter Caravan	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Location of the thrombus within the lungs	To determine the location of the thrombus regions of interest (ROIs) within the lungs using PET-CT imaging in comparison to the ROI of filling defects on CT-angiogram.	4 hours
Primary	Location of clot burden measurements within the thigh	To determine the location of the thrombus ROI within the thigh using PET-CT imaging in comparison to the clot on venous duplex ultrasound.	4 hours
Primary	Assessment of 64Cu-FBP8 fibrin activity in the pelvic and upper extremity	The prevalence of high 64Cu-FBP8 fibrin activity in the pelvic ROI and upper extremity ROI's will be reported.	4 hours
Secondary	Correlation between normalized 64Cu-FBP8 fibrin activity and plasma D-dimer	Correlation of the total fibrin activity in the imaged fields, excluding the liver, gallbladder, kidneys and urinary bladder normalized by injected dose with the plasma D-dimer.	4 hours
Secondary	Overall clot burden within the lungs	Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the lungs.	4 hours
Secondary	Overall clot burden within the thigh	Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the thigh.	4 hours