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

Recruiting now

Conditions studied: Gynecologic Cancer

In brief

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 facts

Study ID

NCT06906705

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

160

Starts

2025-06-06

Expected to finish

2026-04-30

Last updated by the study team

2025-06-12

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Previous radiotherapy treatments
• Previous chemotherapy treatments

Where it is running

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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