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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT06906705
Status
Recruiting
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Conditions

  • Gynecologic Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Apr 2, 2025
Start date
Jun 6, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
160 participants (estimated)

Primary Outcome Measure

Evaluation of HFUS Accuracy in Detecting Lymph Node Metastases in Gynecological Cancer [ Time Frame: Days 20 ]

Central Contacts

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