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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
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 belowSelect...
I have a history of irregular heartbeats.
Select...
I have been diagnosed with cancer.
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I have not been treated with clot-dissolving drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
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 moreTrial 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
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,945 Previous Clinical Trials
13,203,713 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,848 Previous Clinical Trials
47,818,097 Total Patients Enrolled
Ciprian Catana, PhDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart rate is consistently too fast (over 120 beats per minute) or too slow (under 50 beats per minute).I've had chest pain recently but underwent a stress test or coronary angiography afterwards.You have been exposed to too much radiation in the past year according to the Radiology Department's guidelines.I am unable to provide written consent.You have a confirmed blood clot shown on an ultrasound or CT scan, or have a high chance of having a blood clot based on a blood test called D-dimer.I have fainted in the last 6 weeks.I cannot lie comfortably in a PET scanner.You stop breathing for more than 3 seconds during the day.I am not pregnant or breastfeeding, confirmed by a negative pregnancy test.I have a history of irregular heartbeats.I experience severe discomfort in confined spaces.You weigh more than the maximum weight allowed for the MRI or CT table.I have not had heart or major surgery in the last 3 months.I had a heart scan in the last 2 weeks and my blood thinner medication hasn't changed since.You have tested positive for COVID-19 using a specific type of test in the past month.You have metal or electric implants that are not safe for MR-PET scanning when needed.I have been diagnosed with cancer.I have not been treated with clot-dissolving drugs.I am under 18 years old.You have an electrical implant like a pacemaker or a pump.I have had a heart attack in the last 3 months.I have not had a stroke in the past 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Cancer Patients
- Group 2: Other Thrombotic Condition Patients
- Group 3: COVID-19 Patients
- Group 4: Healthy Volunteers
- Group 5: Atrial Fibrillation Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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