HERCULES: Ultrasound-Based Liver Involvement Classification in Ovarian Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Women aged 18 years or older with advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma undergoing complete cytoreductive surgery, with or without suspected liver-area involvement. The study includes both a retrospective cohort of patients treated from March 2026 until Ethics Committee approval and a prospective cohort enrolled after study approval.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 surgery2
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 surgerySponsors and contacts
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Source ClinicalTrials.gov
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