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Study identifier: NCT06621823 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Recruiting

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

Condition: Lymph Node Metastasis · Gynecologic Cancer  ·  Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

PhaseNA
Planned participants160
Who can joinFemale, 18 Years to 99 Years
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

Antonia Carla Testa  ·  0630156399  ·  antoniacarla.testa@policlinicogemelli.it

Elena Teodorico  ·  0630156399  ·  elena.teodorico@policlinicogemelli.it

Always discuss trial participation with your own doctor first.

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyRecruiting

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