The Role of the Imaging FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJules Bordet Institute
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
FAPI PET/CT
Diagnostic testPatient will undergo FAPI PET/CT Prior to surgery
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: patient with liver metastasis from colorectal cancerOther 1 intervention
Trial outcomes
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 weeks2
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 weeks3
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 weeksSecondary 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 weeks2
Correlation between FAPI metabolical volume and MRI tumor volume
Time frame
from enrollment to the surgery date, approximately 3 to 4 weeksSponsors and contacts
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Source ClinicalTrials.gov