PET Fibrin Imaging of DVT and PE

Last updated: December 5, 2023
Sponsor: Peter Caravan
Overall Status: Active - Recruiting

Phase

1

Condition

Venous Thromboembolism

Chest Pain

Claudication

Treatment

64Cu-FBP8

PET-CT imaging

Clinical Study ID

NCT04022915
2018P000523
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Subjects < 18 years of age
  • Time of expected radiotracer injection > 72 hours from the time of a positive venousduplex 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 medicalhistory (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 researchstudies during the prior 12 months, combined with the exposure from this study wouldexceed 50 mSv (millisievert).
  • Due to the radiation exposure from imaging studies, all women of childbearingpotential will be required to have a negative serum pregnancy test performed prior toany imaging procedures on the same day (if not already done that day). Patients with apositive serum pregnancy test will be excluded. Breast feeding women will also beexcluded.
  • A pre-existing condition or use of a medication including vasopressors and tPA (tissuePlasminogen Activator) that in the opinion of the investigator may place the subjectat a substantially increased risk
  • Hemodynamic instability, including requiring escalating doses of vasopressormedication.
  • 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.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: 64Cu-FBP8
Phase: 1
Study Start date:
May 13, 2019
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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