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

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether high-frequency ultrasound — used in real-time during surgery — can accurately assess whether lymph nodes contain cancer in women with gynecological cancers, potentially reducing the need for lengthy pathology wait times and improving surgical decision-making. **You may be eligible if...** - You are a woman between 18 and 99 years old - You are undergoing surgery for a gynecological cancer (ovarian, endometrial, cervical, or vulvar cancer) - Lymph node removal is planned as part of your surgery (for staging or tumor removal purposes) - You do not have any current lymphatic disease - You have not had another cancer diagnosis in the past 5 years - You are willing to participate and can give consent **You may NOT be eligible if...** - You have had prior radiation therapy - You have had prior chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


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