High-frequency ultrasound during gynecologic cancer surgery to check lymph nodes and build radiomics data
Official title: High Frequency Ultrasound Imaging for Intraoperative Lymph Nodal Assessment in Gynecological Cancer: From Image-guided Surgery to Radiomics Applications
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06906705 · Data updated 2026-11-12
We will test whether using high-frequency ultrasound during surgery can help doctors check lymph nodes in women having operations for ovarian, endometrial, cervical, or vulvar cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | Women only |
| Enrollment | 160 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | June 6, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | April 30, 2026 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT06906705 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–99 undergoing surgery for ovarian, endometrial, cervical, or vulvar cancer who need nodal excision, have no recent chemotherapy or radiotherapy, and can give informed consent are ideal candidates.
✕Probably not a fit
Patients who previously received chemotherapy or radiotherapy, those not having nodal surgery, or those with widespread disease where nodal status won't change management are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project uses high-frequency ultrasound (HFUS) to image lymph nodes intraoperatively in women undergoing surgery for gynecologic cancers. Surgeons will perform nodal excision as clinically indicated and capture HFUS images during the operation, with images and clinical data collected prospectively. Images will be analyzed using radiomics methods and compared to standard pathology, sentinel node results, and existing imaging to identify patterns associated with metastasis. The goal is to determine whether HFUS plus radiomics can improve intraoperative lymph node assessment and reduce unnecessary lymphadenectomies.
Why it matters
Potential benefit: If successful, this approach could help avoid unnecessary lymphadenectomies, lowering surgical complications like lymphedema while improving intraoperative detection of nodal metastases.
How similar studies have gone: Sentinel lymph node techniques are established and reduce unnecessary lymphadenectomy, but intraoperative HFUS with radiomics is a relatively novel approach with limited prior clinical validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical, and vulvar cancer) * Need for nodal excision (staging or cytoreductive reasons) * 18-99 years old * Absence of contemporary lymphatic diseases * Absence of previous oncological disease in the last 5 years * Willingness to participate in the study and to provide informed consent Exclusion Criteria: * Previous radiotherapy treatments * Previous chemotherapy treatments
Where it's running
-
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Antonia Carla Testa, Professor — Fondazione Policlinico Universitario Agostino Gemelli
- Study coordinator: Antonia Carla Testa, Professor
- Email: antoniacarla.testa@policlinicogemelli.it
- Phone: 0630156399
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.