Improving colon cancer scans with FAPI PET/CT
Diagnostic Efficacy of 18F-FAPI-74 PET/CT in Patients With Colon Cancer
This study will test whether a new PET tracer called 18F‑FAPI‑74 gives clearer whole-body images to find lymph node spread and distant metastases in people with colon cancer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Turku University Hospital Government |
| Locations | 1 site (Turku) |
| Trial ID | NCT07272772 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center imaging study enrolling 100 patients at Turku PET Centre between 2024 and 2026 to image primary staging and suspected recurrence of colon cancer with 18F‑FAPI‑74 PET/CT. The trial compares the detection of local mesenteric lymph node metastases and distant metastases at the patient level, reporting sensitivity and specificity. The work is motivated by limitations of conventional whole-body CT and 18F‑FDG PET in colon cancer and leverages a tracer that targets fibroblast activation protein on cancer-associated fibroblasts. Scans will be performed as part of routine staging or surveillance and data collected prospectively for diagnostic accuracy analysis.
Who should consider this trial
Good fit: Adults with colon cancer who have suspected mesenteric lymph node metastases on CT, potentially curable metastases, or suspected recurrence or rising CEA, and who have WHO performance status 0–2 and can give informed consent.
Not a fit: Pregnant or breastfeeding people, those unable to undergo whole-body PET/CT, legally vulnerable individuals, or those who cannot consent are not eligible and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the imaging could improve staging accuracy and earlier detection of recurrence, helping doctors choose better treatment plans.
How similar studies have performed: Early studies of FAPI PET tracers in several tumor types have shown promising lesion detection compared with FDG PET, but large prospective data specifically in colon cancer are still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Turku
- Turku PET Centre, Turku University Hospital — Turku, Finland (Recruiting)
Study contacts
- Principal investigator: Saila Kauhanen — Turku PET Centre, Turku University Hospital
- Study coordinator: Saila Kauhanen
- Email: saila.kauhanen@utu.fi
- Phone: +358503017010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.