RecruitingNCT07272772Updated Dec 9, 2025

Colon Cancer Diagnosis With FAPI-PET Imaging

A Phase 2/3 interventional study of PET/CT ([F-18]FAPI-74) in Colon Cancer, sponsored by Turku University Hospital. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Turku University Hospital · Phase 2/3, Interventional, and Diagnostic

From the registry’s dates

Registered 1 year 1 month after the study started (first participant enrolled Oct 2024, registered Nov 2025).
Started Oct 2024; still recruiting 1 year 11 months later.

Phase: Phase 2/3
Study type: Interventional
Enrollment: 100
Allocation: Not applicable
Ages: 18 Years to 85 Years
Sex: All

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.

Conditions studied

Colon Cancer

Browse trials for

Colonic Neoplasms 1,432

Keywords

Positron Emission Tomography
FAPI
Diagnostics
Imaging
Staging

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

Experimental
Staging
Staging
Device: PET/CT ([F-18]FAPI-74)

Interventions

DevicePET/CT ([F-18]FAPI-74)
PET/CT with FAPI-74 tracer is performed

What researchers measure

Primary outcomes

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) 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) 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 locations

1 of 1 sites recruiting

Turku PET Centre, Turku University Hospital
Turku, Finland
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07272772
Lead sponsor: Turku University Hospital
Responsible party: Sponsor
First posted: Dec 9, 2025
Start date: Oct 9, 2024
Primary completion: Oct 2026 (estimated)
Completion: Oct 2026 (estimated)
Last update: Dec 9, 2025

Study contacts

Saila Kauhanen

Contact

saila.kauhanen@utu.fi

+358503017010

Saila Kauhanen

principal investigator · Turku PET Centre, Turku University Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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