Colon Cancer Diagnosis With FAPI-PET Imaging

Last updated: November 26, 2025
Sponsor: Turku University Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Colon Cancer

Colorectal Cancer

Treatment

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

Clinical Study ID

NCT07272772
Colon-FAPI
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with primary colon cancer with suspicion of mesenteric lymph nodemetastases 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/orelevated carcinoembryonic antigen (CEA) in cancer surveillance

  • WHO performance score 0-2

  • Patient signs informed consent form after receiving written information

Exclusion

Exclusion Criteria:

  • Vulnerable study subjects such as described in Finnish law clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not beincluded

  • Patient is not able to understand purpose of study

  • Medical conditions prohibiting whole body PET-CT

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: PET/CT ([F-18]FAPI-74)
Phase: 2/3
Study Start date:
October 09, 2024
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Turku PET Centre, Turku University Hospital

    Turku 633679,
    Finland

    Active - Recruiting

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