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NCT Number: NCT06906705

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

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.

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Key information

Conditions

Gynecologic Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location status: Recruiting

Location contact

ANTONIA CARLA TESTA, Professor

CONTACT

[email protected]

Elena Teodorico, Dr

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Previous radiotherapy treatments
  • Previous chemotherapy treatments

Treatment and study plan

Primary outcomes

  1. Evaluation of HFUS Accuracy in Detecting Lymph Node Metastases in Gynecological Cancer

    Time frame: Days 20

    The aim of this prospective trial is to report the sensivity, specificity, NPV, PPV and accuracy of HFUS in the metastasis detection (macro, micro and ITCs) from fresh, unstained ex vivo/in vivo lymph node samples.

Secondary outcomes

  1. Minimum Size Detection Limit of HFUS Imaging

    Time frame: 2 minutes

    To assess the lowest size detectable with the adopted imaging technique

  2. Development of a Radiomic Algorithm for Lymph Node Assessment

    Time frame: 6 months

    To develop a radiomic algorithm for the assesment of the lymphn node status

Study contacts

Contact information is provided by the study sponsor or research team.

Antonia Carla Testa, Professor

CONTACT

[email protected]

0630156399

Elena Teodorico

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Canon Medical Systems Europe B.V

Registry information

Official study title

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

Acronym: RHINOCERUS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 2, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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