Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07272772

Colon Cancer Diagnosis With FAPI-PET Imaging

Whole body CT is the primary imaging method in staging and follow-up of colon cancer. Conventional PET-CT with 18F-labeled fluorodeoxyglucose (18F-FDG) has its limitations and has a secondary role in colon cancer protocols. A new PET tracer, fibroblast activation protein inhibitor (FAPI), targeting a protein that is overexpressed by cancer-associated fibroblasts presents a potential new PET imaging tool.

The objective of this prospective study is to evaluate diagnostic efficacy of 18F-FAPI-74 PET/CT in patients with colon cancer. The aim is to evaluate the sensitivity and specificity of 18F-FAPI-74 in detection of local lymph node metastasis and distant metastasis in patient level in patients with colon cancer in primary staging and when suspected recurrence. 100 patients with colon cancer are enrolled and PET/CT studies are performed with the novel 18F-FAPI-74 tracer. The data will be collected between 2024-2026.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Turku PET Centre, Turku University Hospital

Turku, Finland

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with primary colon cancer with suspicion of mesenteric lymph node metastases in computed tomography before primary cancer operation
  • Patients with primary colon cancer with potentially curable metastases
  • Patients with suspected metastasis or local recurrence in computed tomography and/or elevated carcinoembryonic antigen (CEA) in cancer surveillance
  • WHO performance score 0-2
  • Patient signs informed consent form after receiving written information

Exclusion criteria

  • Vulnerable study subjects such as described in Finnish law clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included
  • Patient is not able to understand purpose of study
  • Medical conditions prohibiting whole body PET-CT

Treatment and study plan

PET/CT ([F-18]FAPI-74)

Device

PET/CT with FAPI-74 tracer is performed

Primary outcomes

  1. 1) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph node metastasis in patient level in patients with primary colon cancer

    Time frame: 2 years

  2. 2) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of distant metastasis in patient level in patients with primary colon cancer

    Time frame: 2 years

  3. 3) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph metastasis and distant metastasis in patient level in patients with recurrent colon cancer

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Saila Kauhanen

CONTACT

[email protected]

+358503017010

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

Diagnostic Efficacy of 18F-FAPI-74 PET/CT in Patients With Colon Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.