Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Location status: Recruiting
Location contact
ANTONIA CARLA TESTA, Professor
CONTACT
Elena Teodorico, Dr
CONTACT
NCT Number: NCT06621823
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
Interested in participating?
Request Info18 year–99 year
Female
Interventional
Not applicable
Roma, 00168, Italy
Location status: Recruiting
ANTONIA CARLA TESTA, Professor
CONTACT
Elena Teodorico, Dr
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 2 years
The secondary endpoint is to assess the lowest size detectable with the adopted drop-in robotic ultrasound probe
Contact information is provided by the study sponsor or research team.
Antonia Carla Testa
CONTACT
Elena Teodorico
CONTACT
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Acronym: R-LYNUS
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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.
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