PET Fibrin Imaging of DVT and PE

NCT04022915 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 2018P000523R01HL141900
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Deep Vein Thrombosis; Pulmonary Embolism; Venous Thromboembolism

Outcome Measures

Primary Outcomes (3)

• 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.

  72 hours

• 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.

  72 hours

• Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity

  The presence or absence of blood clots as assessed by high 64Cu-FBP8 fibrin activity in the pelvic veins and upper extremities will be reported.

  4 hours

Secondary Outcomes (3)

• Correlation Between Normalized 64Cu-FBP8 Fibrin Activity and Plasma D-dimer

  4 hours

• Overall Clot Burden Within the Lungs

  4 hours

• Overall Clot Burden Within the Thigh

  4 hours

Study Arms (1)

Acute pulmonary embolism

EXPERIMENTAL

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

Drug: 64Cu-FBP8; Diagnostic Test: PET-CT imaging

Interventions

64Cu-FBP8 DRUG

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

Acute pulmonary embolism

PET-CT imaging DIAGNOSTIC_TEST

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

Acute pulmonary embolism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Cu-FBP8 (Copper-64 labeled fibrin binding probe 8) is cleared by the kidneys, patients with eGFR (estimated Glomerular Filtration Rate ) \< 30 will be excluded.

Sponsors & Collaborators

• Peter Caravan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Thromboembolism

Results Point of Contact

• Title: Tilo Winkler
• Organization: Mass General Hospital

twinkler@mgh.harvard.edu

617 724-4083

Study Officials

• Tilo Winkler, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiology

Model Details: Subjects with acute pulmonary embolism meeting the inclusion criteria will be enrolled.

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 17, 2019
• Study Start: May 13, 2019
• Primary Completion: July 19, 2022
• Study Completion: August 26, 2024
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2026-02

Locations

US (1)