RecruitingNCT06906705

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

High Frequency Ultrasound Imaging for Intraoperative Lymph Nodal Assessment in Gynecological Cancer: From Image-guided Surgery to Radiomics Applications


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

160 participants

Start Date

Jun 6, 2025

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Inclusion Criteria6

  • Women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical, and vulvar cancer)
  • Need for nodal excision (staging or cytoreductive reasons)
  • 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 Criteria2

  • Previous radiotherapy treatments
  • Previous chemotherapy treatments

Locations(1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06906705


Related Trials