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Study of Gallium (68Ga) edotreotide, Fluorocholine (18F) and Fludeoxyglucose (18F) PET imaging for detection and staging of liver cancer and gastro-entero-pancreatic tumors

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical study focuses on two types of cancer: hepatocellular carcinoma (a type of liver cancer) and gastro-entero-pancreatic tumors (tumors affecting the digestive system and pancreas). The study will use three different imaging substances: Gallium (68Ga) edotreotide, Fluorocholine (18F), and Fludeoxyglucose (18F), which are administered through intravenous injection to help detect and visualize cancer cells during scanning.

The purpose of this study is to evaluate the effectiveness of combining multiple PET (Positron Emission Tomography) scans into a single imaging session for detecting and determining the stage of these cancers. This approach, called multiplexed imaging, will be compared to traditional single-substance scanning methods.

During the study, participants will receive injections of two different imaging substances through their veins and undergo scanning procedures. The imaging substances are radioactive tracers that help create detailed pictures of areas where cancer might be present in the body. The safety of this combined approach will be monitored, and the quality of the resulting images will be evaluated to determine if this new method provides accurate information about the cancer's location and extent.

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 preparation

    A pregnancy test will be performed for women of childbearing age before starting the procedure

    Your physical condition will be evaluated using the ECOG performance scale (a measure of your ability to perform daily activities)

    A review of your previous CT or MRI scans (performed within the last 6 months) will be conducted to confirm the presence of evaluable lesions

  2. Step 2

    PET imaging procedure

    You will receive two different radioactive substances through intravenous injection

    The radioactive substances used are: gallium (68Ga) edotreotide and either fluorocholine (18F) or fludeoxyglucose (18F)

    The substances will be administered one after another through the same injection site

    You will undergo a single scanning session that combines both imaging agents (multiplexed PET scan)

    Some patients may have the option to undergo a longer, dynamic whole-body scan

  3. Step 3

    Post-procedure monitoring

    You will be monitored for 30 minutes after the completion of the scan to check for any adverse reactions

    Your comfort level during the procedure will be assessed using a scale from 1 to 5

    You will be asked to indicate your preference between this combined scan and traditional separate scans

  4. Step 4

    Follow-up requirements

    Male patients must use contraception (condoms) for 3 months after the scan

    Female patients must use effective contraception for 6 months after the scan

    Partners of male patients must use contraception for 3 months after the scan

    Partners of female patients must use contraception for 6 months after the scan

Who can join the trial?

15 criteria

  • Age 18 years or older
  • Must provide written informed consent to participate
  • Must be covered by French social security system
  • Must have good physical performance status (ECOG score of 2 or less, which means being able to carry out light activities)
  • Must have at least one measurable tumor lesion on CT or MRI scan performed within last 6 months
  • Must be willing and able to attend all scheduled study visits
  • For liver cancer patients: must have good liver function (Child-Pugh A classification) with:
    • Albumin levels above 28 g/L
    • Total bilirubin less than 35 µM/L
    • Confirmed diagnosis by tissue biopsy
    • For patients with GEP-NET (gastro-entero-pancreatic tumors): must have confirmed diagnosis by tissue biopsy and liver or pancreatic involvement
    • For male participants:
      • Must use condoms for 3 months after the PET scan
      • Female partners must use effective contraception for 6 months after the scan
      • For female participants, must meet one of these conditions:
        • Negative pregnancy test and use effective contraception for 6 months after the scan
        • Be post-menopausal (over 50 with no menstrual periods for 12 months)
        • Have had surgical sterilization (documented hysterectomy or removal of ovaries/fallopian tubes)

Who cannot join the trial?

10 criteria

  • Pregnant or breastfeeding women are not eligible to participate
  • Persons under 18 years of age cannot take part in the study
  • Patients who have severe kidney problems (impaired kidney function) cannot participate
  • Those with known allergies to the imaging substances used in PET scans (special medical imaging test) are excluded
  • Patients who cannot lie still for the required scanning time (approximately 30-40 minutes) are not eligible
  • Those who have had other nuclear medicine procedures within the past 24 hours cannot participate
  • Patients with metal implants or devices that could interfere with imaging cannot take part
  • Individuals who weigh more than the scanning equipment's weight limit (usually 350-440 pounds/160-200 kg) are not eligible
  • Patients who cannot provide informed consent on their own are excluded
  • Those participating in other clinical trials at the same time cannot take part in this study
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Investigated drugs

Radiopharmaceutical PET imaging agents - These are special substances used in medical imaging that contain small amounts of radioactive material. They are injected into the body and help create detailed images of tumors during PET (Positron Emission Tomography) scans. In this trial, two different imaging agents are used together in a new approach called multiplexed PET imaging to detect and examine liver cancer (hepatocellular carcinoma) and gastro-entero-pancreatic tumors. Note: The specific names of the radiopharmaceutical agents are not provided in the source data, but the trial involves using two different PET imaging agents in combination.

What is already known about the treatment

Multiplexed PET Imaging – A novel diagnostic imaging technique that involves the simultaneous administration of two different radiopharmaceutical tracers through a single injection route, specifically designed for detecting and staging hepatocellular carcinoma and gastro-entero-pancreatic tumors. This advanced imaging method combines multiple PET scans to provide enhanced diagnostic capabilities compared to traditional single-tracer PET imaging, allowing for better visualization and assessment of tumor presence and spread. The technique is currently being evaluated in clinical trials to determine its safety, technical feasibility, and diagnostic effectiveness, with potential to improve the accuracy of cancer diagnosis and staging procedures while maintaining patient comfort through a single administration process.

Investigated diseases

  • Hepatocellular Carcinoma

    A primary liver cancer that begins in the liver cells called hepatocytes. The disease typically develops gradually over time, often in people with chronic liver conditions. The cancer starts in the liver tissue and can spread to different parts of the organ. As it progresses, it may form one or more tumors within the liver.

  • Gastro-entero-pancreatic Tumors

    A group of rare tumors that can develop in the digestive tract and pancreas. These tumors start in specialized cells called neuroendocrine cells, which are found throughout the digestive system. They can occur in the stomach, intestines, or pancreas. The tumors typically grow slowly over time and can produce various hormones.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519505-35-00Protocol codeRC24_0563Estimated enrolment28 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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