RECRUITING

PET Fibrin Imaging of DVT and PE

Conditions

Pulmonary Embolism Deep Vein Thrombosis Venous Thromboembolism

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

PET Fibrin Imaging of DVT and PE

Quick Facts

Study Start:2019-05-13

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04022915

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Tilo Winkler, PhD

CONTACT

617-724-4083

twinkler@mgh.harvard.edu

Mamary T Kone, MD, MPH

CONTACT

617-726-1082

mkone@mgh.harvard.edu

Principal Investigator

Tilo Winkler, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Peter Caravan

Tilo Winkler, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-13

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2019-05-13

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Pulmonary Embolism
Deep Vein Thrombosis
Venous Thromboembolism