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

NCT06906705 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2025-06-12

No results posted yet for this study

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.

Conditions

  • Gynecologic Cancer

Sponsors & Collaborators

  • Canon Medical Systems Europe B.V

    collaborator UNKNOWN

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Antonia Carla Testa, Professor · Fondazione Policlinico Universitario Agostino Gemelli

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-06
Primary Completion
2025-12-31
Completion
2026-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06906705 on ClinicalTrials.gov