FAPI PET/CT imaging of the tumor microenvironment in colorectal cancer liver metastases
Official title: The Role of FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases: Non-randomized Phase II Molecular Imaging Study
Run by Jules Bordet Institute · NCT07109440 · Data updated 2026-11-12
This will try FAPI PET/CT imaging to highlight cancer-associated fibroblasts and growth patterns in adults with colorectal cancer that has spread to the liver and who are scheduled for surgical removal of their metastases.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Jules Bordet Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brussels) |
| Status | Recruiting |
| Started | May 9, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | August 7, 2025 |
| Trial ID | NCT07109440 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with colorectal cancer and resectable liver metastases who are treatment-naïve or have completed neoadjuvant chemotherapy, have ECOG ≤2, and can provide informed consent are ideal candidates.
✕Probably not a fit
Patients with non-resectable liver metastases, pregnant or lactating women, or those with other significant medical conditions that prevent completion of imaging are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional imaging protocol uses FAPI PET/CT, a molecular scan that targets fibroblast activation protein expressed by cancer-associated fibroblasts, to map the tumor microenvironment in colorectal liver metastases. Adults with resectable liver metastases, either treatment-naïve or after neoadjuvant chemotherapy, undergo FAPI PET/CT prior to planned liver resection. The study compares FAPI uptake patterns with histological growth patterns (HGP) from surgical specimens and tracks changes after systemic therapy. The goal is to determine whether FAPI PET/CT can noninvasively indicate CAF-rich regions and shifts in HGP that are relevant to surgical and systemic treatment planning.
Why it matters
Potential benefit: If successful, this imaging approach could help surgeons and oncologists better plan and personalize treatment by revealing CAF-rich tumor areas and histological growth patterns before surgery.
How similar studies have gone: Early clinical studies of FAPI PET/CT have shown promising tumor uptake and improved lesion detection in several cancers compared with FDG, but using FAPI to define histological growth patterns in colorectal liver metastases is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age above 18 years. * Liver metastasis on standard imaging for the initial assessment (MRI, FDG PET/CT) * Naïve for treatment or after neoadjuvant chemotherapy * Scheduled for liver metastasis resection * ECOG Performance status ≤2. * Signed written informed consent Exclusion Criteria: * Non-resectable liver metastases * Pregnant and lactating women * Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
Where it's running
-
Institut Jules Bordet
Brussels, Belgium Recruiting
Study contacts
- Study coordinator: Loubna Taraji, MS
- Email: loubna.taraji@hubruxelles.be
- Phone: 02.541.37.81
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.