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Study on Gallium (68Ga) Chloride PET/CT for Detecting Lymph Node Metastasis in Patients with Early Rectal Cancer

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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 rectal cancer, a type of cancer that affects the last part of the large intestine. The study is investigating a new imaging method using a special solution called [68Ga]Ga-FAPI-46. This solution is used in a type of scan known as positron emission tomography or PET/CT, which helps doctors see if the cancer has spread to nearby lymph nodes, which are small glands that are part of the immune system.

The purpose of the study is to determine how accurately the [68Ga]Ga-FAPI-46 PET/CT scan can detect cancer spread compared to the results from surgery. The study involves two groups of patients. One group will have the scan before undergoing a surgery called total mesorectal excision (TME), which removes the cancerous part of the rectum. The other group will have the scan after a less invasive procedure called local excision, which removes the tumor without major surgery.

Participants in the study will receive the [68Ga]Ga-FAPI-46 solution through an infusion, which is a way of delivering the solution directly into the bloodstream. The study will last for a short period, and the results will help doctors understand if this new scanning method can improve the detection of cancer spread and potentially change how rectal cancer is managed in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the FARE Trial, an initial assessment is conducted to confirm eligibility. This involves reviewing medical history and current health status to ensure alignment with the trial's inclusion criteria.

    Eligibility criteria include being 18 years or older with suspected or confirmed rectal cancer, specifically cT1-3N0-1M0 for Group A or cT1-2N0M0 for Group B, as determined by MRI and CT scans.

  2. Step 2

    Preparation for imaging

    Participants are prepared for imaging procedures. This includes receiving a solution for infusion containing gallium (68ga) chloride, which is used in the PET/CT scan to help detect lymph node metastasis.

    The infusion is administered prior to the imaging session to allow the substance to circulate and highlight areas of interest during the scan.

  3. Step 3

    PET/CT scan

    A PET/CT scan is performed using the [68Ga]Ga-FAPI-46 tracer. This scan aims to detect lymph node metastasis in early rectal cancer.

    The scan results are compared to standard imaging techniques to assess the diagnostic accuracy of the PET/CT scan.

  4. Step 4

    Surgical procedure

    For Group A, participants undergo a total mesorectal excision (TME) as part of their treatment plan. This surgical procedure is performed to remove the rectal cancer and surrounding tissue.

    For Group B, participants undergo a local excision, which is a less invasive procedure aimed at removing the tumor while preserving surrounding tissue.

  5. Step 5

    Post-surgical evaluation

    Following surgery, the removed tissue is analyzed to confirm the presence or absence of cancerous cells in the lymph nodes.

    The results of this analysis are compared with the initial PET/CT scan findings to evaluate the accuracy of the imaging technique.

  6. Step 6

    Follow-up

    Participants are monitored for any changes in their condition and to assess the long-term outcomes of the treatment and imaging techniques used in the trial.

    Regular follow-up appointments are scheduled to ensure ongoing health and to gather data for the trial's objectives.

Who can join the trial?

8 criteria

  • Patients must be at least 18 years old.
  • For Group A: Patients should have suspected or confirmed rectal cancer that has not spread beyond the nearby tissue, as seen on a standard MRI scan. There should be no signs of cancer spreading to other parts of the body on chest and abdominal CT scans.
  • For Group A: Patients should be scheduled for a primary surgery called TME, which means they haven't had any local surgery or treatment before.
  • For Group A: The local team of doctors specializing in colorectal cancer must approve the primary surgery.
  • For Group B: Patients should have suspected or confirmed rectal cancer that has not spread beyond the muscle layer, as seen on a standard MRI scan. There should be no signs of cancer spreading to other parts of the body on chest and abdominal CT scans.
  • For Group B: Tumors should have specific features seen during an endoscopy, which is a procedure to look inside the body. These features suggest the tumor is suitable for local removal.
  • For Group B: Patients should be planned for a local surgery using specific techniques called EID or TAMIS.
  • For Group B: The local team of doctors specializing in colorectal cancer must approve the local surgery.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with rectal cancer cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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  • Verified

    Amsterdam UMC

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

[68Ga]Ga-FAPI-46 is a special imaging agent used in a type of scan called positron emission tomography (PET/CT). This agent helps doctors see if there are any cancerous lymph nodes in patients with early rectal cancer. It works by highlighting areas in the body where cancer cells might be present, allowing doctors to detect lymph node metastasis more accurately. This can help in planning the best treatment approach for the patient.

What is already known about the treatment

[68Ga]Ga-FAPI-46 – This medication is administered through an injection and is used in positron emission tomography (PET) scans. It is currently being studied in clinical trials for its effectiveness in detecting lymph node metastasis in early rectal cancer. The main therapeutic indication is to improve diagnostic accuracy in identifying cancer spread. At the molecular level, it works by targeting fibroblast activation protein, which is often overexpressed in cancerous tissues, allowing for enhanced imaging of tumors. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Rectal cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It typically starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. As the disease progresses, the cancer cells can invade deeper layers of the rectal wall and potentially spread to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression of rectal cancer can vary, with some cases remaining localized while others may spread to distant parts of the body. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506594-35-00Estimated enrolment50 patientsSponsorAmsterdam UMC Stichting

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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.

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