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NCT Number: NCT07109440

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

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

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Key information

Conditions

Liver Metastases From Colorectal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Jules Bordet

Brussels, 1070, Belgium

Location status: Recruiting

Location contact

Irina Ortansa Vierasu, MD

CONTACT

[email protected]

02.555.82.80

Irina Ortansa Vierasu, MD

PRINCIPAL_INVESTIGATOR

Loubna TARAJI, MS

CONTACT

02.541.3781

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FAPI PET/CT

Diagnostic Test

Patient will undergo FAPI PET/CT Prior to surgery

Primary outcomes

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

    Time frame: from the enrollement to the surgery date, approximately 3 to 4 weeks

  2. The quantification of FAP expression on FAPI PET/CT (SUVmax, SUVmean, MTV [metabolically active tumor volume], FAPI-TV [FAPI positive tumour load])

    Time frame: From enrollment to surgery date, approximately 3 to 4 weeks

  3. correlation between the value of FAPI PET/CT and the percent encapsulated, and the HGP scores (desmoplastic, replacement, pushing) of the liver metastasis

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

Secondary outcomes

  1. Correlation between FAPI PET/CT and FDG PET/CT parameters: (SUV max, SUVmean, metabolical volume)

    Time frame: from enrollment to the surgery date, approximately 3 to 4 weeks

  2. Correlation between FAPI metabolical volume and MRI tumor volume

    Time frame: from enrollment to the surgery date, approximately 3 to 4 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Loubna Taraji, MS

CONTACT

[email protected]

02.541.37.81

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Official study title

The Role of FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases: Non-randomized Phase II Molecular Imaging Study

Acronym: FOAM

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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