[64Cu]FBP8 for Blood Clot

Massachusetts General Hospital, Boston, MA
Blood Clot+3 More Conditions[64Cu]FBP8 - Drug
18 - 85
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Blood Clot
  • Cancer
  • Coronavirus
  • Atrial Fibrillation

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 48 hours

36 hours
Complete blood count
4 hours
Target to Background Ratio
Target to Background Ratio LAA
48 hours
Time activity curve

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

5 Treatment Groups

Healthy Volunteers
1 of 5
COVID-19 Patients
1 of 5
Cancer Patients
1 of 5
Atrial Fibrillation Patients
1 of 5
Other Thrombotic Condition Patients
1 of 5

Active Control

Experimental Treatment

240 Total Participants · 5 Treatment Groups

Primary Treatment: [64Cu]FBP8 · No Placebo Group · Phase 1

COVID-19 PatientsExperimental Group · 2 Interventions: [64Cu]FBP8, PET/MR · Intervention Types: Drug, Device
Cancer PatientsExperimental Group · 2 Interventions: [64Cu]FBP8, PET/MR · Intervention Types: Drug, Device
Atrial Fibrillation PatientsExperimental Group · 2 Interventions: [64Cu]FBP8, PET/MR · Intervention Types: Drug, Device
Other Thrombotic Condition PatientsExperimental Group · 2 Interventions: [64Cu]FBP8, PET/MR · Intervention Types: Drug, Device
Healthy VolunteersActiveComparator Group · 4 Interventions: [64Cu]FBP8, Blood Collection, Electrocardiogram, PET/MR · Intervention Types: Drug, Procedure, Procedure, Device
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3

Trial Logistics


Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48 hours

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,778 Previous Clinical Trials
31,224,443 Total Patients Enrolled
Ciprian Catana, PhDPrincipal InvestigatorMassachusetts General Hospital

Eligibility Criteria

Age 18 - 85 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have fainted in the past 6 weeks.
Your heart rate is either too fast (above 120 beats per minute) or too slow (below 50 beats per minute) for a long period of time.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.