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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method to detect fresh blood clots in the lungs, known as pulmonary embolism (PE), and in the deep veins, called deep venous thrombosis (DVT). The process uses a special PET-CT scan with a new tracer, 64Cu-FBP8 (a fibrin binding probe), to help spot these clots more clearly. Individuals recently diagnosed with a significant pulmonary embolism confirmed by a CT scan, and who can receive the tracer injection within 72 hours, might be suitable for this study. As a Phase 1 trial, this research aims to understand how this new imaging method works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using medications like vasopressors or tPA, you may be excluded from the study, so it's best to discuss your medications with the trial team.

What prior data suggests that this PET-probe is safe for imaging blood clots?

Research has shown that the 64Cu-FBP8 PET-CT scan is generally easy for people to handle. In earlier studies, researchers closely monitored the safety of this new imaging tool. Participants did not report any major side effects. Important health signs, such as heart rate and breathing, were checked before and after the scans, and no significant changes were found.

Additionally, early studies in humans have shown that this scan has low radiation exposure and exits the body quickly through the kidneys. This rapid clearance is a positive indicator for safety. Overall, the findings suggest that 64Cu-FBP8 is safe for detecting blood clots in conditions like pulmonary embolism and deep vein thrombosis. ^{1 2 3 4 5}

Why are researchers excited about this study treatment?

Most treatments for acute pulmonary embolism, like anticoagulants, work by preventing further clotting. But 64Cu-FBP8 is different because it uses a special PET-CT imaging technique to directly visualize and characterize blood clots. This radiotracer binds specifically to fibrin, a protein found in blood clots, allowing doctors to see clots clearly and assess their size and severity. Researchers are excited about this approach because it could lead to more accurate diagnosis and personalized treatment planning, potentially improving patient outcomes by tailoring therapies to the individual's specific condition.

What evidence suggests that 64Cu-FBP8 PET-CT Imaging is effective for detecting blood clots in pulmonary embolism and deep venous thrombosis?

Research has shown that the 64Cu-FBP8 probe is a promising tool for detecting blood clots. In this trial, participants with acute pulmonary embolism will receive the 64Cu-FBP8 probe and undergo PET-CT imaging. The probe targets fibrin, a key protein in clots, enhancing visibility in PET-CT scans. Studies have demonstrated its effectiveness in identifying clots in conditions such as pulmonary embolism (PE) and deep vein thrombosis (DVT). The probe has successfully located these clots in imaging, aiding in more accurate diagnosis and potential treatment of these conditions. ^{1 6 7 8 9}

Who Is on the Research Team?

Tilo Winkler, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4762685/

Radiation dosimetry of the fibrin-binding probe 64Cu-FBP8 ... We tested the feasibility of 64 Cu-FBP8-PET to detect source thrombi and culprit emboli after deep vein thrombosis and pulmonary embolism (DVT-PE).

2. jnm.snmjournals.org jnm.snmjournals.org/content/56/7/1088/tab-figures-data

Radiation Dosimetry of the Fibrin-Binding Probe 64 Cu-FBP8 ... Radiation Dosimetry of the Fibrin-Binding Probe 64Cu-FBP8 and Its Feasibility for PET Imaging of Deep Vein Thrombosis and Pulmonary Embolism in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11230308/

Dosimetry of [64Cu]FBP8: a fibrin-binding PET probe This study presents the biodistribution, clearance and dosimetry estimates of [64Cu]Fibrin Binding Probe #8 ([64Cu]FBP8) in healthy subjects.

4. researchgate.net researchgate.net/publication/276279376_Radiation_Dosimetry_of_the_Fibrin-Binding_Probe_64Cu-FBP8_and_Its_Feasibility_for_PET_Imaging_of_Deep_Vein_Thrombosis_and_Pulmonary_Embolism_in_Rats

Radiation Dosimetry of the Fibrin-Binding Probe 64Cu ... 64 Cu-labeled FBP8, a short chain comprising of 6-aminoacid cyclic peptides, has detected PE and DVT, in SPECT imaging and ex vivo counting ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04022915

NCT04022915 | PET Fibrin Imaging of DVT and PE In this study, we will use the novel fibrin-specific probe 64CU-FBP8 (Copper-64 labeled fibrin binding probe 8) for PET imaging of fresh blood clots in PE and ...

6. jnm.snmjournals.org jnm.snmjournals.org/content/56/7/1088

Radiation Dosimetry of the Fibrin-Binding Probe 64 Cu- ... We tested the feasibility of 64 Cu-FBP8 PET to detect source thrombi and culprit emboli after deep vein thrombosis and pulmonary embolism (DVT-PE).

7. sciencedirect.com sciencedirect.com/science/article/pii/S1936878X21006343

Detection and Characterization of Thrombosis in Humans ... We show in this first-in-human study that PET/CMR of the fibrin-binding PET probe [64Cu]FBP8 can detect acute to subacute LAA thrombi with a sensitivity of 100% ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04022915

NCT04022915 | PET Fibrin Imaging of DVT and PE In this study, we will use the novel fibrin-specific probe 64CU-FBP8 (Copper-64 labeled fibrin binding probe 8) for PET imaging of fresh blood clots in PE and ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39633070/

First-in-human Evaluation of Safety and Dosimetry of [64Cu ... This study demonstrates the following properties of the [ 64 Cu]FBP8 probe: low dosimetry estimates; fast blood clearance and renal excretion; ...