HERCULES: Ultrasound-Based Liver Involvement Classification in Ovarian Cancer

N/ANot Yet RecruitingNCT07808320

Fondazione Policlinico Universitario Agostino Gemelli IRCCS20 enrolled

Overview

This monocentric observational pilot study aims to assess the feasibility of a standardized two-dimensional ultrasound (2D US) approach for the preoperative assessment and anatomo-surgical classification of liver-area involvement in women with advanced or recurrent epithelial ovarian cancer. The study will evaluate whether standardized ultrasound acquisition and reporting can identify the main patterns of liver-area disease and assign them to predefined surgical classes. In patients with parenchymal lesions, the study will also explore the ability of ultrasound to differentiate liver peritoneal infiltration from hematogenous hepatic metastases. Clinical, ultrasound, surgical, and histological data will be collected from a retrospective and prospective cohort. Ultrasound findings will be compared with surgical findings, with histology used as an additional reference standard when available. The study will also develop a standardized ultrasound acquisition protocol and reporting template to improve reproducibility and support preoperative surgical planning.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ovarian Cancer Recurrent Ovarian Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women aged ≥18 years. * Suspicious or histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. * Suspicious primary FIGO stage III-IV disease or recurrent ovarian cancer undergoing complete cytoreductive surgery. * For participants included in the prospective cohort, written informed consent for study participation and processing of personal data. * For the retrospective cohort, eligible participants may include individuals for whom informed consent cannot be obtained because they are deceased or cannot be contacted despite all reasonable efforts to trace them. Data processing will be conducted in accordance with applicable Italian data protection regulations. Exclusion Criteria: \- Previous radiotherapy involving the hepatic area

Outcomes

Primary Outcomes

Feasibility of standardized 2D ultrasound for liver-area anatomo-surgical classification

Proportion of enrolled patients with a complete and evaluable preoperative 2D ultrasound dataset allowing assignment of the anatomo-surgical class of liver-area involvement and, when parenchymal lesions are present, differentiation between liver peritoneal infiltration (LPI) and hematogenous hepatic metastases (HHM).

Time frame: At baseline, before surgery

Secondary Outcomes

Adherence to the standardized 2D ultrasound acquisition protocol

Proportion of ultrasound examinations meeting all predefined mandatory views, measurements, and technical settings according to the standardized acquisition protocol.

Time frame: At baseline, before surgery

Concordance between ultrasound findings and the anatomo-surgical classification

Qualitative comparison between the ultrasound-based classification of liver-area involvement and the anatomo-surgical classification determined from surgical findings, with histological findings used as an additional reference standard when available.

Time frame: At surgery