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

NCT06621823 · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated 15 June 2025

What is being tested
image-guided surgery technique
For
Lymph Node Metastasis; Gynecologic Cancer
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 99 years. About 160 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 25 July 2024, ends 31 May 2026. Registered 1 Oct 2024.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT06621823

Sites

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, Italy