Colon Cancer Diagnosis With FAPI-PET Imaging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PET/CT ([F-18]FAPI-74).
- Who it may be relevant to
- Registry conditions: Colon Cancer. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Diagnostic Efficacy of 18F-FAPI-74 PET/CT in Patients With Colon Cancer
Overview
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
- Device PET/CT ([F-18]FAPI-74)
PET/CT with FAPI-74 tracer is performed
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Finland · 1 center
- Turku PET Centre, Turku University Hospital — Turku
Identifiers
NCT: NCT07272772 · Colon-FAPI