HERCULES: Ultrasound-Based Liver Involvement Classification in Ovarian Cancer

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Recurrent Ovarian Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: At baseline, before surgery

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).

Secondary outcomes

Adherence to the standardized 2D ultrasound acquisition protocol

Time frame: At baseline, before surgery

Proportion of ultrasound examinations meeting all predefined mandatory views, measurements, and technical settings according to the standardized acquisition protocol.
Concordance between ultrasound findings and the anatomo-surgical classification

Time frame: At surgery

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonia Carla Testa

CONTACT

[email protected]

+390630156399

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Ultrasound-based Anatomo-Surgical Classification of Liver-Area Involvement in Ovarian Cancer (HERCULES Study): A Feasibility and Methodology Study

Acronym: HERCULES

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 8, 2026
Registry last updated: Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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