Using robotic ultrasound to evaluate lymph nodes in gynecological cancers
Official title: Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06621823 · Data updated 2026-11-12
This study is testing a new robotic ultrasound method to see if it can help women with gynecological cancers check their lymph nodes during surgery, aiming to reduce the need for more invasive procedures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | Women only |
| Enrollment | 160 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | July 25, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | May 31, 2026 |
| Registry record updated | June 15, 2025 |
| Trial ID | NCT06621823 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18-99 undergoing robotic surgery for gynecological malignancies who require nodal excision.
✕Probably not a fit
Patients with previous radiotherapy or chemotherapy treatments in the area of analyzed lymph nodes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the status of lymph nodes in women undergoing radical surgery for gynecological cancers using an innovative intraoperative robotic ultrasound technique. The goal is to assess lymph node morphology and imaging characteristics to determine the presence of metastasis, potentially reducing the need for extensive lymphadenectomies. By comparing the ultrasound findings with definitive pathology results, the study aims to improve the accuracy of lymph node evaluation and minimize unnecessary surgical complications. This approach could enhance patient outcomes by providing a less invasive option for lymph node assessment.
Why it matters
Potential benefit: If successful, this study could lead to more accurate lymph node evaluations, reducing unnecessary surgeries and associated complications for patients with early-stage gynecological cancers.
How similar studies have gone: While the use of robotic ultrasound in this context is innovative, similar imaging techniques have shown promise in other studies, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women undergoing robotic surgery for gynecological malignancies (ovarian, endometrial, cervical cencers) * 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 in the area of analysed lymph nodes * Previous chemotherapy treatments
Where it's running
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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
- 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.