Heart and Blood Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Thrombosis

Venous Thrombosis

Lung Diseases

Pulmonary Embolism

Embolism

Thromboembolism

Respiration Disorders

Respiratory Tract Diseases

Embolism and Thrombosis

Vascular Diseases

All Drugs and Chemicals

Hematinics

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Fluorodeoxyglucose F18

Calcium

Liver Extracts

Calcium, Dietary

Complete clinical history, along with routine physical, analytical examination (creatinine, sodium, potassium, red series, white series, liver and calcium profile) and chest x-ray.

Limited screening plus positron emission tomography / computed tomography with 18 FDG (18FDG PET-CT).

The performance of the 18 FDG PET-CT will require fasting of at least 6 hours, and the glycemia will have to be lower than 126 mg / dL before the injection of 3-5 MBq / kg of 18FDG. Intravenous injection will follow a period of approximately 60 minutes in a quiet room.

Computed tomography (CT) will be performed from the middle of the forehead to the feet with normal and shallow breathing using a low dose adjustment Iodinated contrast will not be administered intravenously.

Fludeoxyglucose 18F

Luis Jara Palomares, MD/PhD

Clara M Rosso Fernández, MD/PhD

Juan José López Núñez, MD

Gloria de la Red Bellvis, MD

Luis Jara-Palomares, MD

Jesús Aibar Gallizo, MD

Marina Suarez Pinera, MD

Diego Agustin Rodríguez, MD

Fátima del Molino Sanz, MD

Carmen Díaz Pedroche, MD

Alicia Lorenzo Hernández, MD

Vladimir Salazar Rosa, MD

Open and multicenter randomized clinical trial (1:1) comparing limited screening with extended screening with the performance of Positron emission tomography-computed tomography (PET-CT) scan in the search for neoplasms in patients with unprovoked venous thromboembolic disease at high risk of developing cancer at follow-up.

Introduction: Cancer screening in patients with unprovoked venous thromboembolic disease (VTE) is controversial. In the last years, a score has been developed that selects patients at high risk of developing cancer during follow-up.

Objective: To estimate the impact of an active cancer search strategy using 18-fluordesoxiglucose (FDG) PET-CT in unprovoked VTE with high-risk to develop cancer.

Specific Objectives: 1) Number of neoplasms diagnosed in the screening process: 2) number of neoplasms diagnosed at an early stage, 3) impact on survival of the strategy; and 4) impact on the quality of life.

Cancer will be considered from 30 days up to 12 months after the diagnosis of VTE.

Scope: 20 Spanish hospitals. Design: Open-label, multicentre Randomized clinical trial (1: 1) comparing the performance of PET-CT versus limited screening for cancer.

Population: Patients older than 18 years with unprovoked VTE at high risk of presenting cancer at follow-up (≥3 points in the score of Jara-Palomares et al., Chest 2017).

Follow-up: 12 months after VTE. Sample: The sample size calculated is 650 patients, to obtain a power of 80%, with a level of significance of 5%, and taking into account a 10% loss of follow-up.

Screening for Cancer in Patients With Unprovoked VTE

PET / CT Scan to Detect Cancer in Patients With Unprovoked Venous Thromboembolic Disease. Open Randomized Clinical Trial.

IPD to be shared with the center participants once the study is officially finished in the foreseen period of three years.

Estimate the impact of an active cancer search strategy using PET-CT in the number of neoplasms diagnosed in the screening process in patients with high-risk unprovoked thromboembolic disease.

Estimate the impact of an active cancer search strategy using PET-CT in the number of neoplasms diagnosed in early phase in the screening process in patients with high-risk unprovoked thromboembolic disease.

Estimate the impact of an active cancer search strategy using PET-CT in the overall survival in patients with high-risk unprovoked thromboembolic disease.

Estimate the impact of an active cancer search strategy using PET-CT in the quality of life evaluated with the scale EQ-5D in patients with high-risk unprovoked thromboembolic disease. The EQ-5D consists of 2 parts - the "Descriptive System" and the "Visual Analogue scale". The DS comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.

The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Screening for Cancer in Patients With Unprovoked VTE	NCT03937583	Venous Thromboe... Respiratory Dis... Pulmonary Disea... Deep Venous Thr... Pulmonary Embol... Screening Undefined	Fludeoxyglucose...	18 Years -	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Screening for Cancer in Patients With Unprovoked VTE	NCT03937583	Venous Thromboe... Respiratory Dis... Pulmonary Disea... Deep Venous Thr... Pulmonary Embol... Screening Undefined	Fludeoxyglucose...	18 Years -	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Spots Global Cancer Trial Database for fludeoxyglucose 18f