Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies (R-LYNUS)

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

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Lymph Node Metastasis
• Intervention / Treatment: Procedure: image-guided surgery technique

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonia Carla Testa; Phone Number: 0630156399; Email: antoniacarla.testa@policlinicogemelli.it
• Study Contact Backup: Name: Elena Teodorico; Phone Number: 0630156399; Email: elena.teodorico@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Contact: ANTONIA CARLA TESTA, Professor; Email: antoniacarla.testa@policlinicogemelli.it
    • Contact: Elena Teodorico, Dr; Email: elena.teodorico@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: surgical lymph nodes; Patients referred to the Gynecology Oncology Unit in Fondazione Policlinico A. Gemelli IRCCS, Italy, Rome with a diagnosis of gynecological malignancy requiring surgical lymph nodes harvest will be evaluated for the enrolment.	Procedure: image-guided surgery technique; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of RIUS in detecting lymph node metastases (macro-, micro-metastases and isolated tumor cells)	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.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
drop-in robotic ultrasound probe	The secondary endpoint is to assess the lowest size detectable with the adopted drop-in robotic ultrasound probe	2 years

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Antonia Carla Testa, Professor, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome; Study Chair: Francesco Fanfani, Professor, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome; Study Chair: Matteo Pavone, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome; Study Chair: Elena Teodorico, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome; Study Chair: Denis Querleu, Professor, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome; Study Director: Giovanni Scambia, Professor, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Lymphatic Metastasis
• Other Study ID Numbers: 6534

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No