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Study of 18F-FAPI-74 PET/CT Imaging for Detection of Lymph Node Metastases in Patients with Colon Cancer

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study focuses on patients with colon cancer, a type of cancer that develops in the large intestine. The research aims to evaluate a new imaging technique that uses a special radioactive substance called [18F]FAPI-74, which is given as an injection into a vein. This substance is used together with a combined imaging test called PET/CT (Positron Emission Tomography/Computed Tomography) to create detailed pictures of the body.

The main purpose of this research is to determine how well this imaging method can find cancer that has spread to lymph nodes near the colon. During the study, participants will receive a single injection of [18F]FAPI-74 before having the PET/CT scan. The amount of radioactive substance used will not exceed 400 megabecquerels (a unit used to measure radioactivity).

The study will look at different groups of patients: those who have newly diagnosed colon cancer with possible spread to nearby lymph nodes, those who have colon cancer that might be curable despite having spread, and those who are being monitored after previous treatment with suspected return of cancer. The imaging results will help doctors better understand how well this new technique works for detecting the spread of colon cancer.

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 PET/CT scan preparation

    You will receive an intravenous injection of a special diagnostic substance called [18F]FAPI-74.

    This substance helps detect cancer cells during the imaging procedure.

  2. Step 2

    PET/CT scanning procedure

    You will undergo a PET/CT scan, which combines two types of imaging to create detailed pictures of your body.

    The scan will focus on examining your colon area and nearby lymph nodes to detect possible cancer spread.

    The procedure is painless and requires lying still on the examination table.

  3. Step 3

    Image evaluation

    Medical specialists will analyze the scan images to identify any signs of cancer in the colon and surrounding lymph nodes.

    The results will help determine if cancer has spread to nearby areas.

  4. Step 4

    Follow-up assessment

    The study will evaluate how accurately the [18F]FAPI-74 PET/CT scan detected cancer spread.

    Your participation in the imaging study will be complete after the scan and result analysis.

Who can join the trial?

7 criteria

  • You must have primary colon cancer with suspected spread to nearby lymph nodes seen on CT scan, before having surgery to remove the cancer
  • You must have primary colon cancer with metastases (cancer spread) that can potentially be cured
  • You may have suspected return of cancer seen on CT scan and/or elevated levels of CEA (a blood test that can indicate presence of cancer) during follow-up care
  • Your physical ability and daily activity level must be good or moderately reduced (WHO performance score between 0-2, where 0 means fully active and 2 means able to do light activities but resting less than half the day)
  • You must be an adult (18 years or older)
  • You can be either male or female
  • You must read the study information and sign a consent form agreeing to participate

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 65 years
  • Previous treatment for colon cancer including surgery, chemotherapy, or radiation therapy
  • Known allergies to imaging contrast agents or radioactive tracers
  • Pregnant or breastfeeding women
  • Presence of other active cancers besides colon cancer
  • Inability to lie still for the duration of the PET/CT scan (approximately 30 minutes)
  • Severe kidney dysfunction (as it may affect the imaging agent's clearance from the body)
  • Metal implants or devices that could interfere with imaging
  • Weight exceeding the PET/CT scanner table limit (usually 350 pounds/159 kg)
  • Uncontrolled diabetes (as it may affect image quality)
  • Participation in other clinical trials within the past 30 days
  • Mental conditions that prevent providing informed consent
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Investigated drugs

18F-FAPI-74 is a radioactive imaging agent used in PET/CT scans. It is specifically designed to bind to certain proteins that are commonly found in cancer cells. This tracer helps doctors create detailed images of potential cancer spread, particularly focusing on detecting whether colon cancer has spread to nearby lymph nodes. The imaging technique combines PET (Positron Emission Tomography) and CT (Computed Tomography) to provide detailed information about both the location and extent of potential cancer spread.

What is already known about the treatment

18F-FAPI-74 - A radioactive diagnostic tracer administered intravenously for PET/CT imaging, specifically designed to detect cancer cells and metastases in patients with colon cancer. This novel radiopharmaceutical belongs to the class of fibroblast activation protein inhibitors (FAPI) and works by binding to fibroblast activation proteins that are overexpressed in cancer-associated fibroblasts. The substance is currently being investigated in clinical trials to evaluate its effectiveness in detecting lymph node metastases in colon cancer patients, potentially offering more accurate diagnostic imaging compared to conventional methods.

Investigated diseases

Colon cancer - A disease that begins in the large intestine (colon), where healthy cells in the colon develop mutations and start growing uncontrollably. The cancer typically starts as small, benign clumps of cells called polyps that form on the inner lining of the colon. Over time, some of these polyps can become cancerous and grow into the wall of the colon. The disease can spread through the colon wall and may affect nearby lymph nodes. As the disease progresses, cancer cells can travel through blood or lymph vessels to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510651-35-00Estimated enrolment100 patientsSponsorTurku University Hospital

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