NCT07272772 Colon Cancer Diagnosis With FAPI-PET Imaging
| NCT ID | NCT07272772 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Turku University Hospital |
| Condition | Colon Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-10-09 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-10-09 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Saila Kauhanen
PRINCIPAL INVESTIGATOR
Turku PET Centre, Turku University Hospital
Frequently Asked Questions
Who can join the NCT07272772 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Colon Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07272772 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07272772 currently recruiting?
Yes, NCT07272772 is actively recruiting participants. Contact the research team at saila.kauhanen@utu.fi for enrollment information.
Where is the NCT07272772 trial being conducted?
This trial is being conducted at Turku, Finland.
Who is sponsoring the NCT07272772 clinical trial?
NCT07272772 is sponsored by Turku University Hospital. The principal investigator is Saila Kauhanen at Turku PET Centre, Turku University Hospital. The trial plans to enroll 100 participants.
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