The Role of the Imaging FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases

NCT ID: NCT07109440

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-09
• Study Completion Date: 2028-12-31

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

Conditions

Liver Metastases From Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patient with liver metastasis from colorectal cancer

Group Type: OTHER

FAPI PET/CT

Intervention Type: DIAGNOSTIC_TEST

Patient will undergo FAPI PET/CT Prior to surgery

Interventions

FAPI PET/CT

Patient will undergo FAPI PET/CT Prior to surgery

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Jules Bordet

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Loubna Taraji, MS

Role: CONTACT

loubna.taraji@hubruxelles.be

02.541.37.81

Facility Contacts

Irina Ortansa Vierasu, MD

Role: primary

o-i.vierasu@hubruxelles.be

02.555.82.80

Loubna TARAJI, MS

Role: backup

02.541.3781

Other Identifiers

IJB-NM-FOAM

Identifier Type: -

Identifier Source: org_study_id