Colon Cancer
Conditions
Keywords
Positron Emission Tomography, FAPI, Diagnostics, Imaging, Staging
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.
Interventions
DEVICEPET/CT ([F-18]FAPI-74)
PET/CT with FAPI-74 tracer is performed
Sponsors
Turku University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Finland
Contacts
Primary ContactSaila Kauhanen
Outcome results
None listed