Ga68-FAPI-46 PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJules Bordet Institute
About this trial
This is a prospective, phase II, non-randomized clinical imaging trial. Ga68-FAPI-46 is a novel radiotracer used in PET/CT imaging, targeting a protein of the tumor microenvironment called FAP (Fibroblast activation protein).
The aim of the study is to assess the accuracy of Ga68-FAPI-46 PET/CT for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically proven colorectal and ovarian cancer.
Known or suspected peritoneal metastases from the tumour of origin.
Scheduled for peritoneal complete cytoreductive surgery with curative intent with or without neoadjuvant chemotherapy.
ECOG (Eastern Cooperative Oncology Group) Performance status ≤2.
Disqualifiers
Non-resectable extra-abdominal metastasis and/or >3 hepatic metastases on standard work-up
Known chronic inflammatory conditions including the intestinal system (eg. inflammatory bowel disease, Crohn's disease)
Pregnant and lactating women
Previous or concurrent malignancy diagnosed within the last 3 years except adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell skin cancer.
Trial design
Design model
Single group
Treatments tested in this trial
FAPI PET/CT
Diagnostic testThe radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is applied intravenously for molecular imaging of FAP expression with FAPI PET/CT.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: FAPI PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Correlation of the Ga68-FAPI PET/CT derived PCI (peritoneal cancer index) score with the intraoperative PCI based on histopathology of resected specimen (the reference standard)
Intraoperative PCI validated by histopathology performed on resected peritoneal metastases obtained during peritoneal cytoreductive surgery/explorative laparoscopy or laparotomy will be correlated with Ga68-FAPI PET/CT derived PCI.
Time frame
Through completion of post-surgical pathological examination, up to 2 years since the study initiationSecondary outcomes
1
Comparison of PCI obtained with Ga68-FAPI PET/CT to the PCI calculated on standard preoperative imaging.
PCI calculated on standard preoperative imaging (MRI and FDG PET/CT) will be correlated with Ga68-FAPI PET/CT derived PCI.
Time frame
Through completion of imaging examinations, up to 2 years since the study initiation2
Assessment of the impact of neoadjuvant chemotherapy on the FAPI expression of target lesions at baseline.
Subgroup: Patients receiving neoadjuvant chemotherapy Treatment-induced change in the total peritoneal tumor volume and uptake intensity of FAPI on PET/CT will be assessed and correlated to histopathological findings.
Time frame
Through completion of post-neoadjuvant chemotherapy FAPI PET examination,up to 2 years since the study initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov