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.

Screening for cancer with PET / CT in patients with unprovoked venous thromboembolic disease with a high risk of developing cancer. Open randomized clinical trial.

Status

Not yet recruiting

Phases

Phase 2Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003958-25-ES

Enrollment

650

Registered

2019-04-12

Start date

2019-10-25

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous thromboembolic disease

Interventions

Trade Name: Fludesoxiglucosa (18F)- IBA Product Name: Fludesoxiglucosa (18F) Pharmaceutical Form: Anticoagulant and preservative solution for blood INN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.; Secondary Objective: To estimate the impact of an active cancer search strategy using 18DG PET-CT in: - Diagnosis of neoplasms in an early stage. - The impact on survival. - The quality of life. - Cost-effectiveness analysis of the tests carried out. ;Primary end point(s): Number of neoplasms diagnosed by limited screening histology vs. extended (with PET/CT). ; Timepoint(s) of evaluation of this end point: Cancer diagnosis will be considered as cancer diagnosed from 30 days up to 12 months after the diagnosis of venous thromboembolic disease and with histological diagnosis.	—

Measure

Time frame

Main Objective: 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.; Secondary Objective: To estimate the impact of an active cancer search strategy using 18DG PET-CT in: - Diagnosis of neoplasms in an early stage. - The impact on survival. - The quality of life. - Cost-effectiveness analysis of the tests carried out. ;Primary end point(s): Number of neoplasms diagnosed by limited screening histology vs. extended (with PET/CT). ; Timepoint(s) of evaluation of this end point: Cancer diagnosis will be considered as cancer diagnosed from 30 days up to 12 months after the diagnosis of venous thromboembolic disease and with histological diagnosis.

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Secondary

Measure	Time frame
Secondary end point(s): - Recurrent ETV confirmed by imaging tests - Death - Lost in the follow-up - Health expenditure of complementary tests to which the patients have been subjected. ; Timepoint(s) of evaluation of this end point: - Recurrent ETV confirmed by image tests, whether it is positive or negative and also the location. - Cause of the death of the patient since he enters the study until this happens. - Since the patient enters the study until he loses the tracking after a few months of testing. - Health expenditure of complementary tests to which the patients have been subjected: as a routine analysis, chest x-ray or ultrasound.	—

Measure

Time frame

Secondary end point(s): - Recurrent ETV confirmed by imaging tests - Death - Lost in the follow-up - Health expenditure of complementary tests to which the patients have been subjected. ; Timepoint(s) of evaluation of this end point: - Recurrent ETV confirmed by image tests, whether it is positive or negative and also the location. - Cause of the death of the patient since he enters the study until this happens. - Since the patient enters the study until he loses the tracking after a few months of testing. - Health expenditure of complementary tests to which the patients have been subjected: as a routine analysis, chest x-ray or ultrasound.

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Countries

Spain

Contacts

Public ContactUICEC-HUVR

FISEVI

mariaa.lobo.exts@juntadeandalucia.es0034955013414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026