Positron Emission Tomography (PET) Imaging of Thrombosis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03830320
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • [64Cu]FBP8 — DRUG
    Injection of Copper-64 radiopeptide to detect thrombosis
  • PET/MR — DEVICE
    Whole body imaging using Siemens mMR PET/MR scanner
  • Blood Collection — PROCEDURE
    A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
  • Electrocardiogram — PROCEDURE
    A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer

Study Details

The purpose of the study is to evaluate a new radiotracer called 64Cu-FBP8 for PET-MR imaging of thrombosis. The tracer has the potential of detecting thrombosis anywhere in the body, for instance in the left atrial appendage of patients with atrial fibrillation, and thereby may provide a non-invasive alternative to the current standard-of-care methods.

Key Dates

Start date
Apr 1, 2016
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
165 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Healthy Volunteers
    Twenty (20) healthy adult subjects will be injected with \[64Cu\]FBP8 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using PET/MR. Healthy subjects will undergo blood collection before, during, and after the scan. Healthy subjects will also undergo electrocardiogram before and after the scan. An interim review of the data will be conducted after the first six subjects receive the study agent and complete all safety assessments.
  • Experimental: Atrial Fibrillation Patients
    Thirty-five (35) patients with LAA thrombus documented by TEE will be injected with \[64Cu\]FBP8 and imaged for LAA thrombus with MR-PET. The TEE studies in these patients will be part of their routine clinical care. Thirty-five (35) patients with atrial fibrillation and negative TEE will be injected with \[64Cu\]FBP8 and imaged for LAA thrombus. Forty (40) patients with atrial fibrillation who are scheduled for TEE in the upcoming 14 days will be injected with \[64Cu\]FBP8 and imaged for LAA thrombus.
  • Experimental: COVID-19 Patients
    Thirty (30) COVID-19 patients will be injected with \[64Cu\]FBP8 and imaged for thrombi in the body.
  • Experimental: Cancer Patients
    Thirty (30) cancer patients will be injected with \[64Cu\]FBP8 and imaged for thrombi in the body.
  • Experimental: Other Thrombotic Condition Patients
    Fifty (50) patients with other thrombotic conditions will be injected with \[64Cu\]FBP8 and imaged for thrombi in the body.

Primary Outcome Measure

Complete blood count [ Time Frame: 36 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
David E Sosnovik, MD

Find similar trials in Boston, MA

By condition
Atrial fibrillationCOVID-19 / long COVID
By specialty
CardiologyHeart diseaseInfectious disease
By research site
Massachusetts General Hospital· Boston, MA

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