Clinical trial NCT06061874: Ga68-FAPI-46 PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
Official title: Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Peritoneal Carcinomatosis
Keywords: colorectal cancer
ovarian cancer
peritoneal carcinomatosis
fibroblast activation protein inhibitor
positron emission tomography
FAPI-46
PET
FAPI
PET/CT
fibroblast activation protein
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Through completion of post-surgical pathological examination, up to 2 years since the study initiation
Secondary outcomes:
measure: Comparison of PCI obtained with Ga68-FAPI PET/CT to the PCI calculated on standard preoperative imaging.
timeFrame: Through completion of imaging examinations, up to 2 years since the study initiation
measure: Assessment of the impact of neoadjuvant chemotherapy on the FAPI expression of target lesions at baseline.
timeFrame: Through completion of post-neoadjuvant chemotherapy FAPI PET examination,up to 2 years since the study initiation
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
affiliation: Jules Bordet Institute
name: Patrick Flamen
role: PRINCIPAL_INVESTIGATOR
References: