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

NCT06621823 | Recruiting

• 1 other identifier: 6534
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymph Node Metastasis; Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• drop-in robotic ultrasound probe

  2 years

Study Arms (1)

surgical lymph nodes

OTHER

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

Interventions

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.

surgical lymph nodes

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing robotic surgery for gynecological malignancies (ovarian, endometrial, cervical cencers)
• Need for nodal excision (staging or cytoreductive reasons)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Related Publications (1)

• Pavone M, Teodorico E, Bizzarri N, Innocenzi C, Rosati A, Zorzi M, Cantarini C, Ciancia M, Moro F, Gallotta V, Marescaux J, Lecointre L, Fagotti A, Scambia G, Fanfani F, Testa A, Querleu D. Image-Guided Robotic Surgery for Sentinel Lymph Node Status Assessment in Uterine Cancers Using Ultrasound Drop-in Probe: Surgical Technique in 10 Steps. Ann Surg Oncol. 2025 May;32(5):3465-3466. doi: 10.1245/s10434-025-16912-x. Epub 2025 Feb 1.

  PMID: 39893338 DERIVED

MeSH Terms

Conditions

Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonia Carla Testa, Professor

  Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Giovanni Scambia, Professor

  Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome

  STUDY DIRECTOR

Central Study Contacts

Antonia Carla Testa

CONTACT

0630156399; antoniacarla.testa@policlinicogemelli.it

Elena Teodorico

CONTACT

0630156399; elena.teodorico@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: October 1, 2024
• Study Start: July 25, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

IT (1)