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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Gynecologic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06906705

7480

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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