Liver Metastases From Colorectal CancerFOAMNCT07109440
The Role of the Imaging FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases
A study testing FAPI PET/CT in people with Liver Metastases From Colorectal Cancer, run by Jules Bordet Institute at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases From Colorectal Cancer
- What is being tested?
- FAPI PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 9 May 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1070
Irina Ortansa Vierasu, MD, 02.555.82.80, o-i.vierasu@hubruxelles.be
Loubna TARAJI, MS, 02.541.3781
About this study
Official title: The Role of FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases: Non-randomized Phase II Molecular Imaging Study
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
Read the 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
- Being tested
- FAPI PET/CT
- Keywords
- liver metastases from colorectal cancer, FAPI PET/CT, HGP, CAF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI PET/CTDiagnostic test
Patient will undergo FAPI PET/CT Prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| patient with liver metastasis from colorectal cancer | Other | Not described Receives: Diagnostic Test: FAPI PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quantification of IHC staining for FAP-expressing CAFs measured in patient-derived tissue specimens
Measured: 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])
Measured: 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
Measured: 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)
Measured: from enrollment to the surgery date, approximately 3 to 4 weeks
Correlation between FAPI metabolical volume and MRI tumor volume
Measured: from enrollment to the surgery date, approximately 3 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start9 May 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Metastases From Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109440
- Sponsor's protocol ID
- IJB-NM-FOAM
- Acronym
- FOAM
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases: Non-randomized Phase II Molecular Imaging Study
- ClinicalTrials.gov ID
- NCT07109440
- Acronym / sponsor ID
- FOAM / IJB-NM-FOAM
- Conditions
- Liver Metastases From Colorectal Cancer
- Keywords
- liver metastases from colorectal cancer, FAPI PET/CT, HGP, CAF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 9 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with liver metastasis from colorectal cancer | Other | Diagnostic Test: FAPI PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAPI PET/CTPatient will undergo FAPI PET/CT Prior to surgery | Diagnostic test | patient with liver metastasis from colorectal cancer |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAPI PET/CT in people with Liver Metastases From Colorectal Cancer, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Loubna Taraji, MS (02.541.37.81, loubna.taraji@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.