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

Recruitingn/aAges 18 Years - 99 YearsFemaleFondazione Policlinico Universitario Agostino Gem…
NCT06906705 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 tr

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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