HERCULES: Ultrasound-Based Liver Involvement Classification in Ovarian Cancer (HERCULES)

September 7, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Antonia Carla Testa
Phone Number: +390630156399
Email: antoniacarla.testa@policlinicogemelli.it

Study Locations

Italy
- - Roma, Italy, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At baseline, before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline, before surgery
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.	At surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Principal Investigator: Antonia Carla Testa, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

September 7, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)