High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gynecologic Cancer. Basic parameters: 18 years — 99 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
High Frequency Ultrasound Imaging for Intraoperative Lymph Nodal Assessment in Gynecological Cancer: From Image-guided Surgery to Radiomics Applications
Overview
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.
Primary outcome measures
- Evaluation of HFUS Accuracy in Detecting Lymph Node Metastases in Gynecological Cancer [Time frame: Days 20]
Secondary outcome measures (2)
- Minimum Size Detection Limit of HFUS Imaging [Time frame: 2 minutes]
- Development of a Radiomic Algorithm for Lymph Node Assessment [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
Identifiers
NCT: NCT06906705 · 7480