NCT06473766 Ultrasound RF Data for Discriminating Between Benign and Malignant Ovarian Masses
| NCT ID | NCT06473766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-07-15 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Preliminary data (unpublished) on radiomics analysis and ovarian masses provided that benign and malignant ovarian masses with solid morphology have different radiomics features in a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.
Eligibility 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
Contact & Investigator
Antonia Carla Testa, Professor
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
Frequently Asked Questions
Who can join the NCT06473766 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06473766 currently recruiting?
Yes, NCT06473766 is actively recruiting participants. Contact the research team at antoniacarla.testa@policlinicogemelli.it for enrollment information.
Where is the NCT06473766 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06473766 clinical trial?
NCT06473766 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Antonia Carla Testa, Professor at Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome. The trial plans to enroll 50 participants.
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