Using ultrasound RF data to distinguish benign from cancerous solid ovarian masses
Ultrasound RF Data for Discriminating Between Benign and Malignant Ovarian Masses With Solid Ultrasound Morphology, a Feasibility Study
This tests whether ultrasound radiofrequency (RF) data can help tell if a solid ovarian mass in adults is benign or cancerous before surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06473766 on ClinicalTrials.gov |
What this trial studies
The trial collects raw ultrasound RF data from adults with solid ovarian masses (per IOTA terminology) who are scheduled for surgery within 120 days. RF data will be extracted from the preoperative ultrasound exams and linked to surgical pathology results to determine diagnostic accuracy. The work is positioned against existing tools such as the IOTA ADNEX model, which performs well overall but may be less certain for solid masses. The goal is to see if RF-derived information can improve discrimination between benign and malignant lesions.
Who should consider this trial
Good fit: Adults (age 18 or older) with a preoperative ultrasound diagnosis of a solid ovarian mass who will undergo surgery within 120 days and can provide informed consent are ideal candidates.
Not a fit: Patients under 18, those who refuse participation, or those whose ovarian masses are not classified as solid or who are not planning surgery within 120 days are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could improve preoperative diagnosis of solid ovarian masses and help inform surgical planning or reduce unnecessary procedures.
How similar studies have performed: The IOTA ADNEX model has shown very good overall discrimination (AUC ~0.937) for adnexal masses, but using raw ultrasound RF data specifically for solid ovarian masses is a newer approach with limited prior validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Roma
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Antonia Carla Testa, Professor — Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
- Study coordinator: Antonia Carla Testa, Professor
- Email: antoniacarla.testa@policlinicogemelli.it
- Phone: 0630156399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.