An observational study in Gynecologic Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
Lymph node assessment is crucial in gynecological cancers (ovarian, endometrial, cervical, and vulvar), as nodal involvement significantly impacts prognosis and treatment. Despite high morbidity, systematic lymphadenectomy has been widely used for staging and treatment planning. However, in most cases, lymph nodes are free from metastasis, making the procedure unnecessary and exposing patients to severe complications such as lymphedema and infections.
Sentinel lymph node (SLN) evaluation has emerged as a less invasive alternative, reducing unnecessary lymphadenectomies. However, SLN techniques face challenges, including detection failures, inaccurate frozen section analysis, and imaging limitations like false negatives in FDG PET/CT scans. The need for improved intraoperative imaging techniques is emphasized to enhance lymph node assessment, minimize surgical risks, and better tailor treatment approaches.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Evaluation of HFUS Accuracy in Detecting Lymph Node Metastases in Gynecological Cancer
The aim of this prospective trial is to report the sensivity, specificity, NPV, PPV and accuracy of HFUS in the metastasis detection (macro, micro and ITCs) from fresh, unstained ex vivo/in vivo lymph node samples.
Time frame: Days 20
Minimum Size Detection Limit of HFUS Imaging
To assess the lowest size detectable with the adopted imaging technique
Time frame: 2 minutes
Development of a Radiomic Algorithm for Lymph Node Assessment
To develop a radiomic algorithm for the assesment of the lymphn node status
Time frame: 6 months
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS