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HIPAA Compliant
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Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
FEMALE
ID06621823

Robotic Intraoperative Ultrasound to Evaluate Lymph Node Status in Women With Gynecological Cancers

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-06-15

160

Participants Needed

1

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

The trial focuses on women with gynecological cancers such as ovarian, endometrial, and cervical cancers who require robotic surgery involving lymph node removal. It aims to evaluate an image-guided ultrasound technique used during robotic surgery to assess lymph node status and detect metastases. This approach seeks to improve upon current staging methods by reducing unnecessary extensive lymphadenectomies that can cause complications, while helping to guide surgical and pathological decisions more accurately. Participants will undergo intraoperative robotic ultrasound using a drop-in probe to examine lymph nodes while still in the body. The study compares the ultrasound findings against the definitive pathology results to determine how well the technique detects lymph node metastases, including macro- and micro-metastases and isolated tumor cells. The use of this imaging technique may help avoid the risks and drawbacks of traditional frozen section analysis and extensive lymph node removal. During the study, women scheduled for robotic surgery for gynecological malignancies will have their lymph nodes examined with the ultrasound probe. Researchers will evaluate lymph node morphology and imaging characteristics, monitor the sensitivity of the robotic ultrasound in detecting metastases over two years, and assess the use of the drop-in ultrasound probe. Participation involves standard surgical care plus the additional ultrasound assessment, with data collected for research purposes throughout the procedure and follow-up period.

CONDITIONS

Brief Title

Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies

Research Team

A

Antonia Carla Testa

E

Elena Teodorico

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