Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06621823

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

The assessment of lymph node status is of crucial importance in gynaecological malignancies.

Indeed, the prognosis and adjuvant treatment regimens are strongly influenced by the presence of nodal involvement. Systematic extensive lymphadenectomies are often performed for staging, diagnosis of skip metastases and to define the radiation field when radiotherapy treatments are required. Nevertheless, these can lead to significant short-term and long-term lymphatic complications, which are difficult to justify if the lymph nodes are free from metastasis. To avoid unnecessary comprehensive procedures in early-stage cancers, evaluation of the sentinel lymph node has acquired a valuable role even if limitations are still present (rate of frozen section false negative, "empty packets" and mapping failure). The introduction of an intra-operative non-invasive imaging technique capable of describing the presence and characteristics of lymph nodes could help in (1) eliminating the risk of empty packet, (2) orienting the intraoperative decision while avoiding the drawbacks of frozen section (time and resources, partial destruction of the tissue material), (3) orientate the pathological section if frozen section is used. To date, technological advancements have paved the way for enhanced intra-operative assessment of cancerous organs and lesions. Over the past decade, the evolution of robotic surgery combined with advancements in image-guided surgery techniques has led to the introduction of ultrasound probes designed specifically for intraoperative ultrasound during robotic surgery (RIOUS). Apart from the conventional rigid laparoscopic probes, which can be inserted through an accessory trocar, there are robotic probes tailored to fit device arms, and drop-in flexible probes that are becoming increasingly relevant in the scientific panorama. Notably, the latter drop-in probes feature a rigid segment designed for compatibility with robotic graspers, leveraging the dexterity and rotational manoeuvrability inherent to robotic surgery. Such probes, already proven effective in evaluating liver and kidney lesions as well as tumour margins, hold promise for intraoperative lymph node assessments due to the possibility of reaching difficult anatomical spaces thanks to the robotic-assisted movements

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location status: Recruiting

Location contact

ANTONIA CARLA TESTA, Professor

CONTACT

[email protected]

Elena Teodorico, Dr

CONTACT

[email protected]

About this study

Women undergoing radical surgery for gynecological cancers who meet the inclusion criteria in absence of exclusion criteria will be considered candidate for the study. Intraoperative robotic ultrasound will be performed on in vivo lymph nodal samples. Lymph nodes morphology and imaging characteristics will be evaluated. The gold standard will be definitive pathology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

image-guided surgery technique

Procedure

The identification of an image-guided surgery technique capable of intraoperatively detecting the presence of lymph node metastases would overcome the disadvantages and complications of extensive staging lymphadenectomies.

Primary outcomes

  1. Sensitivity of RIUS in detecting lymph node metastases (macro-, micro-metastases and isolated tumor cells)

    Time frame: 2 year

    The aim of this prospective trial is to evaluate the sensitivity of Real-time Intraoperative Ultrasound (RIUS) in detecting lymph node metastases, including macrometastases, micrometastases, and isolated tumor cells (ITCs), using fresh, unstained in vivo lymph node samples. Ultrasound images will be assessed according to the VITA (Vulva International Tumor Analysis) group consensus on morphological parameters. Final histopathological examination will serve as the gold standard for comparison.

Secondary outcomes

  1. drop-in robotic ultrasound probe

    Time frame: 2 years

    The secondary endpoint is to assess the lowest size detectable with the adopted drop-in robotic ultrasound probe

Study contacts

Contact information is provided by the study sponsor or research team.

Antonia Carla Testa

CONTACT

[email protected]

0630156399

Elena Teodorico

CONTACT

[email protected]

0630156399

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: R-LYNUS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.