Cancer, Peritoneal Carcinomatosis
Conditions
Keywords
colorectal cancer, ovarian cancer, peritoneal carcinomatosis, fibroblast activation protein inhibitor, positron emission tomography, FAPI-46, PET, FAPI, PET/CT, fibroblast activation protein
Brief summary
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.
Detailed description
Fibroblast activation protein (FAP) is a type II transmembrane glycoprotein expressed on the surface of cancer-associated fibroblasts (CAFs) in the stroma of various tumor entities. Recently, radiolabeled molecules targeting the FAP, called FAP inhibitors (FAPI) labelled with Gallium-68, have been developed for molecular imaging with PET/CT (positron emission tomography/computed tomography). This radiotracer often presents a higher cancer lesion detectability than F18-FDG (fluorodeoxyglucose), partly thanks to its higher tumour-to-background ratio achieved by a low background activity, particularly in the brain, abdominal cavity and liver. These advantages have resulted in a superior sensitivity of Ga68-FAPI PET/CT over F18-FDG and higher SUV (standardized uptake value) in evaluating various types of cancer. In this context, Ga68-FAPI PET/CT seems promising to further study as a clinical imaging modality for preoperative assessment of peritoneal carcinomatosis. In this study, the investigators correlate Ga68-FAPI PET/CT findings in terms of peritoneal involvement with intraoperative findings based on histopathology and try to find out how accurate Ga68-FAPI PET/CT is for the preoperative assessment of peritoneal carcinomatosis.
Interventions
DIAGNOSTIC_TESTFAPI PET/CT
The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is applied intravenously for molecular imaging of FAP expression with FAPI PET/CT.
Sponsors
Jules Bordet Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Signed written informed consent obtained before any study-specific screening procedures.
Exclusion criteria
* 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. * Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Through completion of post-surgical pathological examination, up to 2 years since the study initiation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of PCI obtained with Ga68-FAPI PET/CT to the PCI calculated on standard preoperative imaging. | Through completion of imaging examinations, up to 2 years since the study initiation | PCI calculated on standard preoperative imaging (MRI and FDG PET/CT) will be correlated with Ga68-FAPI PET/CT derived PCI. |
| Assessment of the impact of neoadjuvant chemotherapy on the FAPI expression of target lesions at baseline. | Through completion of post-neoadjuvant chemotherapy FAPI PET examination,up to 2 years since the study initiation | 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. |
Countries
Belgium
Contacts
Primary ContactLoubna Taraji Schiltz
Outcome results
None listed