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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
Retrospective enrollment: TEE to evaluate LAA within the last 14 days, provided the anticoagulation regimen the patient is on is not changed after the TEE
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 had a heart scan in the last 2 weeks and my blood thinner medication hasn't changed since.
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I have been diagnosed with cancer.
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I have not been treated with clot-dissolving drugs.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete blood count
Target to Background Ratio
Target to Background Ratio LAA
+1 more

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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,299,272 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,258 Total Patients Enrolled
Ciprian Catana, PhDPrincipal InvestigatorMassachusetts General Hospital

Media Library

[64Cu]FBP8 Clinical Trial Eligibility Overview. Trial Name: NCT03830320 — Phase 1
Blood Clot Research Study Groups: Cancer Patients, Other Thrombotic Condition Patients, COVID-19 Patients, Healthy Volunteers, Atrial Fibrillation Patients
Blood Clot Clinical Trial 2023: [64Cu]FBP8 Highlights & Side Effects. Trial Name: NCT03830320 — Phase 1
[64Cu]FBP8 2023 Treatment Timeline for Medical Study. Trial Name: NCT03830320 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for this trial including individuals over 25 years old?

"This clinical trial is open to those aged 18 and over, up until the age of 85."

Answered by AI

Has [64Cu]FBP8 received the necessary regulatory approval from the FDA?

"Our company's evaluation of [64Cu]FBP8's safety gave it a score of 1, which is the lowest on this scale. This rating reflects that there is only minimal clinical data available to assess its efficacy and safety profile."

Answered by AI

Is my involvement in this experiment permissible?

"This clinical trial requires enrolment of 240 participants between the ages 18 and 85 with thrombus. Furthermore, certain criteria need to be met for prospective enrollment: TEE must be completed in next 14 days; SARS-CoV-2 RNA detected by RT-PCR collected from upper or lower respiratory tract analyzed within last month; patient not requiring mechanical ventilation; diagnosed with cancer; ultrasound or CT confirmed/high likelihood of thrombus (e.g., elevated D-dimer); no prior use of thrombolytics and a history of atrial fibrillation/paroxysmal atrial fibrillation"

Answered by AI

Is there still availability for participation in this experiment?

"Affirmative. Clinicaltrials.gov's records reveal that this study, which was launched on August 1st 2016, is actively searching for volunteers to take part in the experiment. A total of 240 subjects are required from one distinct medical centre."

Answered by AI

What is the maximum capacity of participants in this trial?

"Affirmative. The information accessible on clinicaltrials.gov states that recruitment for this investigation is ongoing. It was first posted back in August 1st 2016 and the latest update occurred February 3rd 2022, with an aim of enrolling 240 patients at a single site."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
~27 spots leftby Oct 2025