FAPeCa: Ga68-FAPI-46 PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis

Sponsor

Jules Bordet Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT06061874

Collaborator

(none)

Enrollment

Location

Arm

30.1

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Peritoneal Carcinomatosis	Diagnostic Test: FAPI PET/CT	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis

Actual Study Start Date :

May 30, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FAPI PET/CT Patients with known or suspected peritoneal metastases from colorectal and ovarian cancers scheduled for complete cytoreductive surgery undergo FAPI PET/CT before the planned surgery. In the target population, patients receiving neoadjuvant chemotherapy undergo FAPI PET/CT both before and after chemotherapy.	Diagnostic Test: FAPI PET/CT The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is applied intravenously for molecular imaging of FAP expression with FAPI PET/CT.

Arm

Intervention/Treatment

Experimental: FAPI PET/CT

Patients with known or suspected peritoneal metastases from colorectal and ovarian cancers scheduled for complete cytoreductive surgery undergo FAPI PET/CT before the planned surgery. In the target population, patients receiving neoadjuvant chemotherapy undergo FAPI PET/CT both before and after chemotherapy.

Diagnostic Test: FAPI PET/CT

The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is applied intravenously for molecular imaging of FAP expression with FAPI PET/CT.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.