Clinical trial · Interventional
The Role of the Imaging FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases
The Role of FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases: Non-randomized Phase II Molecular Imaging Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
FAPI PET/CT molecular imaging represents a cutting-edge advancement in oncological imaging, particularly for the preoperative assessment of colorectal liver metastases (CRLM). Fibroblast activation protein inhibitors (FAPIs), which are the focus of this imaging modality, selectively target cancer-associated fibroblasts, a critical component of the tumor microenvironment. FAPI PET/CT could be useful in the detection of HGP (Histological Growth Pattern) and in the changes during neoadjuvant chemotherapy prior to surgery
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases From Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FAPI PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- patient with liver metastasis from colorectal cancer
- interventionNames
- Diagnostic Test: FAPI PET/CT
Primary outcomes (3)
- measure
- The quantification of IHC staining for FAP-expressing CAFs measured in patient-derived tissue specimens
- timeFrame
- from the enrollement to the surgery date, approximately 3 to 4 weeks
- measure
- The quantification of FAP expression on FAPI PET/CT (SUVmax, SUVmean, MTV [metabolically active tumor volume], FAPI-TV [FAPI positive tumour load])
- timeFrame
- From enrollment to surgery date, approximately 3 to 4 weeks
- measure
- correlation between the value of FAPI PET/CT and the percent encapsulated, and the HGP scores (desmoplastic, replacement, pushing) of the liver metastasis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available