Colon Cancer Diagnosis With FAPI-PET Imaging

NCT07272772 | Recruiting Phase 2 DMC

• 1 other identifier: Colon-FAPI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Colon Cancer

Keywords

Positron Emission Tomography; FAPI; Diagnostics; Imaging; Staging

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  2 years

Study Arms (1)

Staging

EXPERIMENTAL

Staging

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

Interventions

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

PET/CT with FAPI-74 tracer is performed

Staging

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku PET Centre, Turku University Hospital

Turku, Finland

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Saila Kauhanen

  Turku PET Centre, Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saila Kauhanen

CONTACT

+358503017010; saila.kauhanen@utu.fi

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: October 9, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)