Screening for cancer with a very effective imaging technique to early tumors in patients with unprovoked venous thromboembolic disease with a slight risk of developing cancer. Open randomized clinical trial.
- Conditions
- Venous thromboembolic diseaseTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2018-003958-25-ES
- Lead Sponsor
- Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 650
1. Over 18 years.
2. Diagnosis of venous thromboembolic disease (proximal deep vein thrombosis of lower limbs, pulmonary embolism or both) unprovoked.
3. High risk classification according to previously published and validated scale (Jara-Palomares et al., Chest, 2016)
4. Signature of informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 650
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Impossibility to continue an adequate follow-up.
2. Contrast hypersensitivity used for PET / CT (8-fluor deoxy-glucose (18FDG)) or any of the excipients according to the characteristics of the product.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method