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

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.

Eligibility

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.

Conditions2

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