Authorised Therapeutic confirmatory (Phase III) Thromboembolic event

Screening for occult malignancy using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in patients with unprovoked venous thromboembolism

EU CTIS ID: 2024-514703-34-00

What this study is testing

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.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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)

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.