What side effects are associated with this type of intervention?

Common treatments for blood clots, such as anticoagulants like low molecular weight heparin (LMWH), primarily carry the risk of increased bleeding, which can range from minor to severe. Regular monitoring is essential to manage this risk. FDG PET/CT, an imaging technique used to detect metabolic activity and abnormalities, can help identify underlying conditions like cancer that may contribute to clot formation. The side effects of FDG PET/CT are generally minimal but include radiation exposure and potential allergic reactions to the tracer.

What prior FDA approvals exist?

The FDA has approved several anticoagulants and antiplatelet agents for the treatment of blood clots. Notable anticoagulants include warfarin, rivaroxaban, and apixaban, which help prevent clot formation and are used in various conditions such as deep vein thrombosis (DVT) and pulmonary embolism (PE). Antiplatelet agents like aspirin and clopidogrel are also approved and commonly used to reduce the risk of clotting events, particularly in patients with cardiovascular diseases. These treatments are relevant in the context of FDG PET/CT imaging, as identifying and managing blood clots is crucial for patients who may have underlying malignancies detected through this imaging technique.

What other types of research exist?

Promising novel alternatives to FDG PET/CT for detecting occult cancers in blood clot patients include PET/MRI, whole-body MRI, and advanced radiotracers such as 68Ga-DOTATATE and PSMA. These techniques offer higher sensitivity and may detect metastatic lesions at earlier stages compared to conventional imaging.

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Diagnostic Test

Cancer Screening for Blood Clots (MVTEP2/SOME2 Trial)

N/A

Recruiting

Research Sponsored by University Hospital, Brest

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 50 years or older with a new diagnosis of first unprovoked proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) will be eligible to participate into the study.

Unprovoked VTE is defined as the absence of any of the following predisposing factors: recently bedridden for period of 3 or more days, or major surgery, within the previous 12 weeks requiring general or regional anaesthesia

Must not have

VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year of follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if using a special imaging test called FDG-PET/CT can better detect hidden cancers in patients who have had their first unprovoked blood clot. The test works by using a sugary dye that cancer cells absorb, making them visible on the scan. The goal is to see if this method finds more hidden cancers compared to standard screening.

Who is the study for?

This trial is for people aged 50 or older who have had a blood clot (VTE) without any clear cause. They shouldn't have known clotting disorders, active cancer in the last 5 years, recent major surgery, paralysis, or been bedridden recently. Participants must be able to give consent and commit to follow-up appointments.

What is being tested?

The study is testing two ways of screening for hidden cancers in patients with unexplained blood clots: standard limited cancer screening versus adding a special imaging test called FDG PET/CT that can find cancer.

What are the potential side effects?

There may be some side effects from the FDG PET/CT scan such as allergic reactions to the tracer used in the test. However, these are generally rare and most people do not experience significant side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 or older and have a new diagnosis of DVT or PE.

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My blood clot was not caused by recent surgery or being bedridden.

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My blood clot occurred without any known cause.

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My blood clot was not caused by a previous clot.

Exclusion Criteria

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

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I had a blood clot despite being on blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year of follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year of follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year of follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Occult cancer missed by screening strategies

Secondary study objectives

Additional tests

Cancer-related mortality

Cost effectiveness analysis

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Limited cancer screening + FDG PET/CTExperimental Treatment1 Intervention

Limited screening + FDG PET/CT

Group II: Limited cancer screeningActive Control1 Intervention

Limited screening alone.

0 / 5Eligibility 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 blood clots include anticoagulants and antiplatelet agents. Anticoagulants, such as warfarin and direct oral anticoagulants (DOACs), work by inhibiting various factors in the blood coagulation pathway, thereby preventing the formation and growth of clots. Antiplatelet agents, like aspirin, prevent platelets from clumping together, which is crucial in the early stages of clot formation. These treatments are vital for blood clot patients as they reduce the risk of clot propagation and recurrence, which can lead to serious complications like stroke or pulmonary embolism. Imaging techniques like FDG PET/CT are important in this context as they can detect metabolic activity and abnormalities, potentially identifying occult cancers that might have triggered the clot, thus guiding more comprehensive patient management.