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PET Probe

64Cu-FBP8 PET-CT Imaging for Blood Clots

Phase 1
Recruiting
Led By Tilo Winkler, PhD
Research Sponsored by Peter Caravan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older with a clinically significant pulmonary embolus (PE) confirmed by a filling defect in CT angiography (CTA)
Subjects must receive the radiotracer injection within 72 hours of their diagnosis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours
Awards & highlights

Study Summary

This trial will test a new imaging tool to help diagnose PE and DVT by looking for fresh clots in the vascular system.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions related to the radiotracer injection such as discomfort at the injection site. Since it involves radiation exposure, there's also a risk similar to that associated with other types of medical imaging procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older and have a confirmed pulmonary embolism.
Select...
I received a special injection within 3 days of being diagnosed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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
Assessment of 64Cu-FBP8 fibrin activity in the pelvic and upper extremity
Thigh structure
Location of the thrombus within the lungs
Secondary outcome measures
Correlation between normalized 64Cu-FBP8 fibrin activity and plasma D-dimer
Overall clot burden within the lungs
Overall clot burden within the thigh

Trial Design

1Treatment groups
Experimental Treatment
Group I: Acute pulmonary embolismExperimental Treatment2 Interventions
Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging.

Find a Location

Who is running the clinical trial?

Peter CaravanLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,299,357 Total Patients Enrolled
6 Trials studying Deep Vein Thrombosis
1,840 Patients Enrolled for Deep Vein Thrombosis
Peter David CaravanLead Sponsor

Media Library

64Cu-FBP8 (PET Probe) Clinical Trial Eligibility Overview. Trial Name: NCT04022915 — Phase 1
Deep Vein Thrombosis Research Study Groups: Acute pulmonary embolism
Deep Vein Thrombosis Clinical Trial 2023: 64Cu-FBP8 Highlights & Side Effects. Trial Name: NCT04022915 — Phase 1
64Cu-FBP8 (PET Probe) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04022915 — Phase 1

Frequently Asked Questions

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

Is this research endeavor presently open to new participants?

"Indeed, the clinicaltrials.gov website confirms that enrollment is ongoing for this medical study which was initially listed on May 13th 2019. As of July 15th 2019, 80 participants are needed to be recruited from a single site."

Answered by AI

Has the 64Cu-FBP8 drug been authorized by the FDA?

"Our team at Power judged the safety of 64Cu-FBP8 to be a 1 because this is an early stage trial. Thus, there exists marginally supporting evidence for efficacy and barely any regarding potential risks."

Answered by AI

What is the cap on the number of participants involved in this medical research?

"Affirmative. Clinicaltrials.gov's data confirms that this clinical research is actively recruiting participants; a process which began on May 13th, 2019 and was most recently updated 15 July 2019. 80 volunteers are being sought from 1 medical centre for the study."

Answered by AI
~3 spots leftby Jun 2024