What side effects are associated with this type of intervention?

Common treatments for Deep Vein Thrombosis (DVT) include anticoagulants such as warfarin, low-molecular-weight heparin (LMWH), and direct oral anticoagulants (DOACs) like dabigatran, rivaroxaban, apixaban, and edoxaban. The primary side effect of these medications is an increased risk of bleeding, which can range from minor bruising to major or life-threatening hemorrhages. Warfarin requires regular blood monitoring due to its narrow therapeutic window and potential for interactions with food and other medications. DOACs, while having more predictable pharmacokinetics and fewer dietary restrictions, still carry a risk of bleeding and may cause gastrointestinal upset. LMWH is generally well-tolerated but can cause injection site reactions and, rarely, heparin-induced thrombocytopenia (HIT).

What prior FDA approvals exist?

The FDA has approved several anticoagulant drugs for the treatment of Deep Vein Thrombosis (DVT), including low molecular weight heparins (e.g., enoxaparin), direct oral anticoagulants (DOACs) such as rivaroxaban, apixaban, and dabigatran, and warfarin. These medications help prevent the formation of new clots and the growth of existing clots. In terms of imaging, traditional methods like ultrasound and venography have been used to diagnose DVT. The novel PET-probe being studied aims to enhance imaging of fresh intravascular blood clots, potentially offering more precise detection and monitoring of DVT.

What other types of research exist?

Promising alternatives to PET-probe imaging for DVT patients include: 1) Magnetic Resonance Direct Thrombus Imaging (MRDTI), which provides high-resolution images of thrombi without the need for contrast agents. 2) Contrast-Enhanced Ultrasound (CEUS), which uses microbubble contrast agents to enhance the visualization of blood flow and clots. 3) Dual-Energy CT Angiography (DECTA), which differentiates between clots and surrounding tissues by using two different X-ray energy levels. These methods offer non-invasive, accurate imaging options for DVT diagnosis and management.

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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 David 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)

Be older than 18 years old

Must not have

Due to the radiation exposure from imaging studies, all women of childbearing potential will be required to have a negative serum pregnancy test performed prior to any imaging procedures on the same day (if not already done that day). Patients with a positive serum pregnancy test will be excluded. Breast feeding women will also be excluded

Women subjects of childbearing potential who are pregnant, seeking to become pregnant, or have a positive serum pregnancy (beta-HCG) test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 hours

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I am not pregnant, trying to get pregnant, or have a positive pregnancy test.

Select...

I need increasing doses of medication to maintain my blood pressure.

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My kidney function is good, with an eGFR of 30 or higher.

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 hours

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of 64Cu-FBP8 fibrin activity in the pelvic and upper extremity

Thigh structure

Location of the thrombus within the lungs

Secondary study objectives

Correlation between normalized 64Cu-FBP8 fibrin activity and plasma D-dimer

Overall clot burden within the lungs

Overall clot burden within the thigh

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Acute pulmonary embolismExperimental Treatment2 Interventions

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Deep Vein Thrombosis (DVT) include anticoagulants such as low-molecular-weight heparin (LMWH), direct oral anticoagulants (DOACs) like rivaroxaban and apixaban, and warfarin. These medications work by inhibiting various factors in the coagulation cascade, thereby preventing the formation and growth of blood clots. LMWH and DOACs offer the advantage of more predictable pharmacokinetics and fewer dietary restrictions compared to warfarin. This is crucial for DVT patients as it reduces the risk of clot propagation and subsequent complications such as pulmonary embolism. The development of imaging techniques like the Novel PET-probe for detecting fresh blood clots can further enhance the management of DVT by allowing for more precise monitoring of treatment efficacy.