Ultrasound RF Data for Discriminating Between Benign and Malignant Ovarian Masses (RFDATA)

June 13, 2025 updated by: Testa Antonia Carla, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Ultrasound RF Data for Discriminating Between Benign and Malignant Ovarian Masses With Solid Ultrasound Morphology, a Feasibility Study

Ultrasound imaging provides useful information for the characterization of ovarian masses as benign or malignant. The most accurate mathematical model to categorize ovarian masses is the IOTA ADNEX model.This model estimates the risk of malignancy and performs similarly to subjective assessment by an experienced ultrasound examiner for discriminating between benign and malignant adnexal masses. The ability of IOTA ADNEX to discriminate between benign and malignant masses is very good (area under the receiver operator characteristic curve 0.937 (95% CI: 0.915-0.954). The ADNEX model maintains its accuracy even in the hands of operators with different experience and training.

According to IOTA terminology, 13% of ovarian masses detected on ultrasound examination are classified as solid. Solid ovarian masses have a risk of malignancy of 60%-75%2 and the discrimination between benign and malignant in this morphological category is challenging. Additionally, it has been estimated that 30% (25/84; 95% CI 18 to 44%) of solid malignant ovarian masses are metastases from non-ovarian tumors. The discrimination between primary ovarian cancer and metastatic tumors in the ovary is also clinically important for planning adequate therapeutic procedures. It is worth exploring the predictive performance of the diagnostic tools in identifying ovarian masses with ultrasound solid morphology.

Preliminary data (unpublished) on radiomics analysis and ovarian masses provided that benign and malignant ovarian masses with solid morphology have different radiomics features in a monocentric retrospective study. However, no statistically significant differences have been observed between primary ovarian cancer and metastases to the ovary.

A new technology is emerging in engineering ultrasound field: the analysis of ultrasound summed RF data- raw data generated by the interface of ultrasound beams with human tissues. To date, raw data are not utilized for conventional imaging and their eventual role in clinical practice is unknown. Indeed, summed RF data could better correlate with biological parameters then parameters identifiable in B-mode images. Summed RF data could also improve radiomic analysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

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

Study Contact Backup

Study Locations

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

No

Description

Inclusion Criteria:

  1. Patients with a preoperative ultrasound diagnosis of a solid ovarian mass (solid according to IOTA terminology, i.e. 80% of the tumor consists of solid tissue).
  2. Patients who will undergo surgery within 120 days after the ultrasound examination.
  3. Patients at least 18 years old.
  4. Informed consent signed.

Exclusion Criteria:

  1. Patients under 18 years of age.
  2. Patient refusal

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Feasibility of RF data to compare RF data in ovarian masses

To evaluate the feasibility of RF data in patients with ovarian masses with solid ultrasound morphology

  1. To compare RF data in benign and malignant ovarian masses with ultrasound solid morphology. Histology will be the reference standard.
  2. To compare RF data in primary invasive and metastases to the ovary.
  3. To describe the reliability of RF data between different images of the same solid ovarian tumor.
Diagnostic test: RF data extraction

To will be acquired:

10 S-Harmonic images (5 in longitudinal plane, 5 in orthogonal plane), 10 B-mode fundamental images (without Harmonic), 1 gray-scale video clip, 1 gray-scale 3D vol will be stored in Harmonic settings and RF-preset.

The Region of interest (ROI) of each image will be manually segmented by a trained gynecologist using the software Aliza version 1.48. The ROI will include only the solid component of the mass. Additional analysis will be performed by using a predefined ROI (area 2x2 cm2). Radiomic features will be extracted using the MODDICOM, an open-source in-house software solution developed by the Knowledge Based Oncology Labs (Rome, Italy) for quantitative imaging analysis fully compliant with the Image Biomarker Standardization Initiative recommendations. The features will be considered: intensity-based statistical and textural.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of examinations readable
Time Frame: At time of ultrasound examination
Feasibility measured as number of examinations readable, (i.e. number of patients with successful process with diagnosed solid ovarian masses, and acquisition of readable RF data)
At time of ultrasound examination

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Samsung Medison

Investigators

  • Principal Investigator: Antonia Carla Testa, Professor, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome

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 (Actual)

July 15, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6267

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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