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Taking people in ItalyNo phase

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

Key facts

Where
Roma, ItalySee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 99 years old?

Source: NCT06906705, who can take part

Where in Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Trial code
NCT06906705
Record updated
12 June 2025
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Previous radiotherapy treatments; Previous chemotherapy treatments.

ClinicalTrials.gov NCT06906705