Gynecologic Cancer
Conditions
Keywords
ovarian cancer, endometrial cancer, cervical cancer, vulvar cancer, HFUS
Brief summary
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.
Interventions
None listed
Sponsors
Canon Medical Systems Europe B.V
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of HFUS Accuracy in Detecting Lymph Node Metastases in Gynecological Cancer | 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
| Measure | Time frame | Description |
|---|---|---|
| Minimum Size Detection Limit of HFUS Imaging | 2 minutes | To assess the lowest size detectable with the adopted imaging technique |
| Development of a Radiomic Algorithm for Lymph Node Assessment | 6 months | To develop a radiomic algorithm for the assesment of the lymphn node status |
Countries
Italy
Contacts
Primary ContactAntonia Carla Testa, Professor
Backup ContactElena Teodorico
Outcome results
None listed