Clinical trial NCT04022915: PET Fibrin Imaging of DVT and PE
Official title: PET Fibrin Imaging of DVT and PE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pulmonary Embolism
Deep Vein Thrombosis
Venous Thromboembolism
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-07-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects with acute pulmonary embolism meeting the inclusion criteria will be enrolled.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Location of the thrombus within the lungs
timeFrame: 4 hours
measure: Location of clot burden measurements within the thigh
timeFrame: 4 hours
measure: Assessment of 64Cu-FBP8 fibrin activity in the pelvic and upper extremity
timeFrame: 4 hours
Secondary outcomes:
measure: Correlation between normalized 64Cu-FBP8 fibrin activity and plasma D-dimer
timeFrame: 4 hours
measure: Overall clot burden within the lungs
timeFrame: 4 hours
measure: Overall clot burden within the thigh
timeFrame: 4 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Tilo Winkler, PhD
role: PRINCIPAL_INVESTIGATOR
References: