Skip to content

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07109440
Acronym
FOAM
Enrollment
50
Registered
2025-08-07
Start date
2025-05-09
Completion date
2028-12-31
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Metastases From Colorectal Cancer

Keywords

liver metastases from colorectal cancer, FAPI PET/CT, HGP, CAF

Brief summary

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

Detailed description

The tumor microenvironment (TME) plays an important role in tumor development and therapeutic response. The understanding of the TME components, especially cancer-associated fibroblasts (CAFs) remains limited. CAFs are among the most abundant and versatile components of the tumor stroma and they are implicated in all the hallmarks of cancer. They have a heterogenous phenotype within a single cell. Some CAFs may have immunosuppressive properties. In liver, there are two obvious physiological sources of CAFs: resident portal fibroblasts (PFs) and hepatic stellate cells (HSCs) . A recent study showed that based on the gene expression profile there are three major subsets of CAFs in colorectal primary tumors and in liver metastasis, including secretory CAFs, ECM-remodeling CAFs and contractile CAFs . In patients undergoing resection of colorectal liver metastasis (CRLMs) the histological growth patterns (HGP) reflect tumor biology and local infiltrating behavior . The HGPs of liver metastases reflect the ways in which cancer cells interact with the surrounding liver. The transition from one HGP to another could occur in patients with CRLM following systemic treatment . 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 and in the changes during neoadjuvant chemotherapy prior to surgery

Interventions

DIAGNOSTIC_TESTFAPI PET/CT

Patient will undergo FAPI PET/CT Prior to surgery

Sponsors

Jules Bordet Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The quantification of IHC staining for FAP-expressing CAFs measured in patient-derived tissue specimensfrom the enrollement to the surgery date, approximately 3 to 4 weeks
The quantification of FAP expression on FAPI PET/CT (SUVmax, SUVmean, MTV [metabolically active tumor volume], FAPI-TV [FAPI positive tumour load])From enrollment to surgery date, approximately 3 to 4 weeks
correlation between the value of FAPI PET/CT and the percent encapsulated, and the HGP scores (desmoplastic, replacement, pushing) of the liver metastasisfrom the enrollment to the anapathological analysis date,approximately 4 to 5 weeks

Secondary

MeasureTime frame
Correlation between FAPI PET/CT and FDG PET/CT parameters: (SUV max, SUVmean, metabolical volume)from enrollment to the surgery date, approximately 3 to 4 weeks
Correlation between FAPI metabolical volume and MRI tumor volumefrom enrollment to the surgery date, approximately 3 to 4 weeks

Countries

Belgium

Contacts

Primary ContactLoubna Taraji, MS
loubna.taraji@hubruxelles.be02.541.37.81

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026