Actively Recruiting

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

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

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

160

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

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

Who Can Participate

Age: 18Years - 99Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women undergoing robotic surgery for gynecological malignancies (ovarian, endometrial, cervical cancers)
  • Need for nodal excision (staging or cytoreductive reasons)
  • Age between 18 and 99 years
  • No current lymphatic diseases
  • No previous oncological disease in the last 5 years
  • Willingness to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Previous radiotherapy treatments in the area of analysed lymph nodes
  • Previous chemotherapy treatments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo robotic surgery during which intraoperative robotic ultrasound is performed on lymph nodes to evaluate their morphology and imaging characteristics.

1 surgical visit (in-person) and immediate post-operative monitoring

Post-operative Follow-up

Duration - Up to 2 years

Participants are monitored after surgery to assess outcomes and collect data on the diagnostic performance of the imaging technique compared to pathology.

Periodic follow-up visits up to 2 years

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

Actively Recruiting

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Research Team

A

Antonia Carla Testa

E

Elena Teodorico

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Image-Guided Robotic Surgery for Sentinel Lymph Node Status Assessment in Uterine Cancers Using Ultrasound Drop-in Probe: Surgical Technique in 10 Steps.

Matteo Pavone, Elena Teodorico, Nicolò Bizzarri...

https://pubmed.ncbi.nlm.nih.gov/39893338