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

NCT07109440 | Recruiting

• 1 other identifier: IJB-NM-FOAM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Metastases From Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• The quantification of IHC staining for FAP-expressing CAFs measured in patient-derived tissue specimens

  from 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 metastasis

  from the enrollment to the anapathological analysis date,approximately 4 to 5 weeks

Secondary Outcomes (2)

• 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 volume

  from enrollment to the surgery date, approximately 3 to 4 weeks

Study Arms (1)

patient with liver metastasis from colorectal cancer

OTHER

Diagnostic Test: FAPI PET/CT

Interventions

FAPI PET/CT DIAGNOSTIC_TEST

Patient will undergo FAPI PET/CT Prior to surgery

patient with liver metastasis from colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, 1070, Belgium

RECRUITING

Central Study Contacts

Loubna Taraji, MS

CONTACT

02.541.37.81; loubna.taraji@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 7, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

BE (1)