Clinical trial NCT06621823: Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies
Official title: Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymph Node Metastasis
Gynecologic Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of RIUS in detecting lymph node metastases (macro-, micro-metastases and isolated tumor cells)
timeFrame: 2 year
Secondary outcomes:
measure: drop-in robotic ultrasound probe
timeFrame: 2 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
name: Antonia Carla Testa, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
name: Francesco Fanfani, Professor
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
name: Matteo Pavone, MD
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
name: Elena Teodorico, MD
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
name: Denis Querleu, Professor
role: STUDY_CHAIR
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
name: Giovanni Scambia, Professor
role: STUDY_DIRECTOR
References: