2024-514703-34-00Not yet recruitingPhase 3
Screening for occult malignancy using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in patients with unprovoked venous thromboembolism
Centre Hospitalier Regional Et Universitaire De Brest10 sites in 1 country638 target enrollmentStarted: June 18, 2024Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 638
- Locations
- 10
- Primary Endpoint
- Occult cancer “missed” by cancer screening defined as proven cancer diagnosed (either biopsy proven cancer or cancer diagnosis approved by adjudication committee in the absence of biopsy proven cancer) from the time of cancer screening completion to the end of the 1-year follow-up period, and not detected at the time of screening.
Study Overview
Brief Summary
To determine whether adding a FDG-PET/CT to a limited screening strategy misses less cancer than a limited cancer screening strategy alone in patients aged 50 years or older with a first unprovoked VTE over a 1-year follow-up period.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Occult cancer “missed” by cancer screening defined as proven cancer diagnosed (either biopsy proven cancer or cancer diagnosis approved by adjudication committee in the absence of biopsy proven cancer) from the time of cancer screening completion to the end of the 1-year follow-up period, and not detected at the time of screening.
Occult cancer “missed” by cancer screening defined as proven cancer diagnosed (either biopsy proven cancer or cancer diagnosis approved by adjudication committee in the absence of biopsy proven cancer) from the time of cancer screening completion to the end of the 1-year follow-up period, and not detected at the time of screening.
Secondary Outcomes
- 2) Early-stage (T1-2N0M0 as per the World Health Organization TNM classification system) and advanced-stage tumors at initial screening and during follow-up.
- 1) New cancer diagnosis after completion of the initial allocated screening strategy.
- 3) Cancer-related mortality during a 5-year follow-up period.
- 4) Diagnosis of cancer and costs from the viewpoint of the healthcare system over a one-year period in order to estimate the additional cost per additional cancer detected and the incremental cost utility ratio
- 5) Additional tests following each strategy and during follow-up.
- 6) The data of this study will be used to develop a decision aid to assist future patients in the decision of cancer screening
Investigators
Clinical trial manager
Scientific
Centre Hospitalier Regional Et Universitaire De Brest
Study Sites (10)
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