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Screening for Hidden Cancer Using FDG PET/CT and Gallium (68Ga) Chloride in Patients Aged 50+ with Unexplained Blood Clots

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying unprovoked venous thromboembolism (VTE), which includes conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE). These are blood clots that occur without an obvious reason. The study is also interested in detecting hidden or "occult" cancer in patients who have experienced their first unprovoked VTE. The trial will use a special imaging technique called 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) to help find any hidden cancers. This imaging method combines two types of scans to provide detailed pictures of the inside of the body.

The purpose of the study is to see if using FDG PET/CT can find more hidden cancers compared to a more limited cancer screening approach. Patients who are 50 years or older and have recently been diagnosed with their first unprovoked VTE will be part of this study. The study will last for one year, during which participants will undergo the FDG PET/CT scan and follow-up checks to monitor for any signs of cancer. The study will also compare the results of this new screening method with traditional methods to see which is more effective in detecting cancer early.

Participants will receive an injection of a special substance called Gallium (68Ga) Chloride, which helps highlight areas of interest in the body during the scan. This substance is part of a product known as GalliaPharm. Some participants may receive a placebo instead. The study aims to improve cancer detection in patients with unprovoked VTE and to understand the potential benefits and costs of using advanced imaging techniques like FDG PET/CT in routine cancer screening. The findings from this study may help develop better screening strategies for future patients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening

    Upon joining the study, the initial step involves a screening process using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT). This imaging technique helps in identifying any hidden cancer in patients with a recent thromboembolic event, such as deep vein thrombosis or pulmonary embolism.

  2. Step 2

    Administration of gallium chloride

    The study involves the use of a radiopharmaceutical called GalliaPharm, which contains gallium (68ga) chloride. This is administered as a solution for injection through an intravenous route. The dosage ranges from 0.74 to 1.85 GBq, depending on the specific requirements of the imaging procedure.

  3. Step 3

    Follow-up period

    After the initial screening and administration of the radiopharmaceutical, there is a follow-up period lasting one year. During this time, the study monitors for any cancer that might have been missed during the initial screening. This includes any new cancer diagnoses and the stage of tumors detected.

  4. Step 4

    Evaluation of outcomes

    The study evaluates several outcomes, including the detection of early-stage and advanced-stage tumors, cancer-related mortality over a five-year period, and the cost-effectiveness of the screening strategy. The data collected will also contribute to developing a decision aid for future patients considering cancer screening.

Who can join the trial?

6 criteria

  • Patients must be **50 years or older**.
  • Must have a new diagnosis of **first unprovoked proximal deep vein thrombosis (DVT)** or **pulmonary embolism (PE)** within the last 4 weeks. DVT is a blood clot in a deep vein, usually in the leg. PE is a blood clot in the lungs.
  • Should not have had recent **paralysis** (loss of muscle function), **paresis** (weakness of voluntary movement), or been **immobilized** (unable to move) for more than 3 days due to an acute medical condition or had a plaster cast on the lower limbs in the last 3 months.
  • Should not have had **major surgery** in the past 3 months that required general or regional anesthesia.
  • Should not have **biological or clinical thrombophilia**, which means a tendency to form blood clots.
  • Should not have an **active malignancy**, which means no known cancer that is progressing or has been treated in the last 5 years, except for adequately treated basal or squamous cell skin cancer. Patients whose health suggests the presence of cancer at the time of VTE diagnosis cannot participate.

Who cannot join the trial?

4 criteria

  • Patients who have had a **thromboembolic event**. This means a condition where a blood clot forms in a blood vessel and can block blood flow.
  • Patients who currently have **cancer**. This refers to a disease where cells in the body grow uncontrollably and can spread to other parts of the body.
  • Patients who are under the age of 50. The study is only for those aged 50 years or older.
  • Patients who have not experienced a first unprovoked **VTE**. VTE stands for venous thromboembolism, which is a condition where a blood clot forms in a vein without an obvious cause.
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Investigated drugs

18F-Fluorodeoxyglucose (FDG) is a type of imaging agent used in PET/CT scans. It helps to highlight areas of the body where there might be cancer by showing how cells in the body are using sugar. This is because cancer cells often use more sugar than normal cells. In this trial, FDG is used to help find hidden cancers in patients who have had a blood clot without a known cause.

What is already known about the treatment

18F-Fluorodeoxyglucose (FDG) – This medication is administered intravenously and is used in combination with Positron Emission Tomography/Computed Tomography (PET/CT) scans. It is currently utilized in medical imaging to detect cancer and assess metabolic activity in tissues. The main therapeutic indication is for the detection of occult malignancies, particularly in patients with unprovoked venous thromboembolism. At the molecular level, FDG is a glucose analog that accumulates in high-glucose-using cells, such as cancer cells, allowing them to be visualized during imaging. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

  • Thromboembolic event

    A thromboembolic event occurs when a blood clot forms in a blood vessel and then travels to another part of the body, potentially causing a blockage. This can happen in veins or arteries and may lead to complications depending on where the clot lodges. Common sites for these events include the lungs, known as pulmonary embolism, or the brain, which can result in a stroke. The condition often arises suddenly and can cause symptoms such as pain, swelling, or difficulty breathing. Risk factors include prolonged immobility, certain medical conditions, and lifestyle factors. The progression can vary, with some clots resolving on their own while others may lead to significant health issues.

  • Cancer

    Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. These cells can invade nearby tissues and form tumors, which may disrupt normal bodily functions. Cancer can develop in almost any part of the body and is often named for the organ or type of cell in which it starts. The progression of cancer can vary widely, with some types growing slowly and others rapidly. Factors such as genetic mutations, environmental exposures, and lifestyle choices can influence its development. As cancer progresses, it may spread to other parts of the body, a process known as metastasis.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514703-34-00Protocol code29BRC20.0021Estimated enrolment638 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).