64Cu-FBP8 PET-CT Imaging for Blood Clots

Overseen By Mamary T Kone, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Peter David Caravan

Must not be taking: Vasopressors, tPA

Disqualifiers: Pregnancy, Breastfeeding, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new imaging tool that helps doctors see fresh blood clots in patients with PE and DVT. It uses a special substance that binds to the clots, making them visible on a PET scan. This could improve diagnosis, especially for patients with kidney or lung problems.

Research Team

Tilo Winkler, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with a recent diagnosis of pulmonary embolism or deep vein thrombosis confirmed by CT scans. Participants must be able to lie flat for 45 minutes and have adequate kidney function. Pregnant women, those exceeding weight limits for PET imaging, or individuals exposed to high levels of radiation in the past year are excluded.

Inclusion Criteria

I am 18 or older and have a confirmed pulmonary embolism.

I received a special injection within 3 days of being diagnosed.

Exclusion Criteria

I cannot lie flat for 45 minutes due to a condition like back pain or arthritis.

My eligibility is not affected by my race, sex, or ethnicity.

I am not pregnant or breastfeeding, confirmed by a test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 64Cu-FBP8 and undergo PET-CT imaging to assess thrombus location and clot burden

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• 64Cu-FBP8
• PET-CT Imaging

Trial Overview The study tests a new PET scan probe called 64Cu-FBP8 designed to detect fresh blood clots in lungs and veins. It aims to see how well this probe works compared to current diagnostic methods within three days of clot diagnosis.

Participant Groups

Group I: Acute pulmonary embolism Experimental Treatment 2 Interventions

Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging.

Who Is Running the Clinical Trial?

Peter David Caravan

Lead Sponsor

Trials

1

Recruited

80+

Peter Caravan

Lead Sponsor

Trials

2

Recruited

140+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+