The Role of the Imaging FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FAPI PET/CT.
- Who it may be relevant to
- Registry conditions: Liver Metastases From Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Role of FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases: Non-randomized Phase II Molecular Imaging Study
Overview
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 test FAPI PET/CT
Patient will undergo FAPI PET/CT Prior to surgery
Primary outcome measures
- 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]
- 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]
- 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 outcome measures (2)
- 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]
- Correlation between FAPI metabolical volume and MRI tumor volume [Time frame: from enrollment to the surgery date, approximately 3 to 4 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Belgium · 1 center
- Institut Jules Bordet — Brussels
Identifiers
NCT: NCT07109440 · IJB-NM-FOAM