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

Phase 1

Conditions: Embolism venous Neoplasm malignant
MedDRA version: 21.1Level: PTClassification code 10028997Term: Neoplasm malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: PTClassification code 10014522Term: Embolism venousSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2020-002210-41-FR

Lead Sponsor: CHRU 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) as detailed below will be eligible to participate into the study.
-No recent (less than 3 months) paralysis, paresis, or plaster immobilization of lower extremities;
- No major surgery (within the past 3 months) requiring general or regional anaesthesia;
- No known thrombophilia;
- No active malignancy (known malignancy, progressive and/or treated during the last 5 years) except for adequately treated basal or squamous cell carcinoma

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 238
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

Patients will be excluded from the study if they have any of the following criteria:
1) Hypersensitivity to 18F-FDG or any of the excipients according to the product monograph;
2) Unavailable to follow-up;
3) VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin)
4) VTE provoked by a major inherited or acquired risk factor;
5) Refusal or inability to provide informed consent;
6) Life expectancy <12 months;
7) Ongoing pregnancy