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Recruiting NCT06906705

High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics

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Trial Parameters

Condition Gynecologic Cancer
Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Type OBSERVATIONAL
Phase N/A
Enrollment 160
Sex FEMALE
Min Age 18 Years
Max Age 99 Years
Start Date 2025-06-06
Completion 2025-12-31

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical, and vulvar cancer) * 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 * Previous chemotherapy treatments

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