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PET Imaging for Blood Clots

Phase 1

Recruiting

Led By Ciprian Catana, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of atrial fibrillation or paroxysmal atrial fibrillation

Patient is diagnosed with cancer

Must not have

Does not have the ability to give written informed consent

History of syncope within the last 6 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new radiotracer to see if it can detect thrombosis (clots) in the body using PET-MR imaging. This could provide a non-invasive alternative to current methods.

Who is the study for?

This trial is for adults with atrial fibrillation or cancer, who've had a recent test confirming no changes in their blood clotting status, and have tested positive for COVID-19 within the last month. It's not for those under 18, pregnant or breastfeeding women, people over certain weight limits, those with electrical implants like pacemakers, or anyone unable to undergo PET/MR imaging.

What is being tested?

[64Cu]FBP8 is being tested as a new radiotracer in PET-MR scans to detect thrombosis (blood clots) non-invasively. The study will include additional procedures like blood collection and electrocardiograms to assess the tracer's effectiveness compared to standard methods.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions related to the injection of the radiotracer [64Cu]FBP8 or discomfort from lying still during imaging procedures such as PET/MR scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a history of irregular heartbeats.

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I have been diagnosed with cancer.

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I have not been treated with clot-dissolving drugs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to provide written consent.

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I have fainted in the last 6 weeks.

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I cannot lie comfortably in a PET scanner.

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I experience severe discomfort in confined spaces.

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I am under 18 years old.

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I have had a heart attack in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete blood count

Target to Background Ratio

Target to Background Ratio LAA

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Other Thrombotic Condition PatientsExperimental Treatment2 Interventions

Fifty (50) patients with other thrombotic conditions will be injected with \[64Cu\]FBP8 and imaged for thrombi in the body.

Group II: Cancer PatientsExperimental Treatment2 Interventions

Thirty (30) cancer patients will be injected with \[64Cu\]FBP8 and imaged for thrombi in the body.

Group III: COVID-19 PatientsExperimental Treatment2 Interventions

Thirty (30) COVID-19 patients will be injected with \[64Cu\]FBP8 and imaged for thrombi in the body.

Group IV: Atrial Fibrillation PatientsExperimental Treatment2 Interventions

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.

Group V: Healthy VolunteersActive Control4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET/MR

2018

Completed Phase 3

~100

0 / 9Eligibility criteria met