Using robotic ultrasound to evaluate lymph nodes in gynecological cancers
Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Roma) |
| Trial ID | NCT06621823 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-99 undergoing robotic surgery for gynecological malignancies who require nodal excision.
Not a fit: Patients with previous radiotherapy or chemotherapy treatments in the area of analyzed lymph nodes may not benefit from this study.
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 performed: While the use of robotic ultrasound in this context is innovative, similar imaging techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
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 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
- 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.