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Screening for occult malignancy using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in patients with unprovoked venous thromboembolism

Phase 1
Conditions
Thromboembolic event, Cancer
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Registration Number
CTIS2024-514703-34-00
Lead Sponsor
Centre Hospitalier Regional Et Universitaire De Brest
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
638
Inclusion Criteria

Patients aged 50 years or older with a new diagnosis of first unprovoked proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) = 4 weeks as detailed below will be eligible to participate into the study., No recent paralysis, paresis, or prolonged immobilization> 3 days for acute medical condition or plaster cast of the lower limbs in the last 3 months., No major surgery (within the past 3 months) requiring general or regional anaesthesia, No biological or clinical thrombophilia, No active malignancy (known malignancy, progressive and/or treated during the last 5 years) except for adequately treated basal or squamous cell carcinoma. Patients whose state of health suggests the presence of cancer at the time of diagnosis of VTE cannot be included in the protocol.

Exclusion Criteria

Hypersensitivity to 18F-FDG or any of the excipients according to the product monograph, Unavailable to follow-up, VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin), VTE provoked by a major inherited or acquired risk factor, Refusal or inability to provide informed consent, Life expectancy <12 months, Ongoing pregnancy, Vulnerable individuals (Persons deprived of their liberty by judicial or administrative decision; Persons under psychiatric care under duress; Persons admitted to a health or social institution for purposes other than research; Persons of full age subject to a legal protection measure; persons under protective custody)

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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