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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-06

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gynecologic Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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