Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canon Medical Systems Europe B.V | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of HFUS Accuracy in Detecting Lymph Node Metastases in Gynecological Cancer | 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. | Days 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Size Detection Limit of HFUS Imaging | To assess the lowest size detectable with the adopted imaging technique | 2 minutes |
| Development of a Radiomic Algorithm for Lymph Node Assessment | To develop a radiomic algorithm for the assesment of the lymphn node status |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients referred to the Gynecology Oncology Unit in Fondazione Policlinico A. Gemelli
IRCCS, Italy, Rome with a diagnosis of gynecological malignancy requiring surgical lymph nodes harvest will be evaluated for the enrolment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonia Carla Testa, Professor | Contact | 0630156399 | antoniacarla.testa@policlinicogemelli.it | |
| Elena Teodorico | Contact | elena.teodorico@guest.policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonia Carla Testa, Professor | Fondazione Policlinico Universitario Agostino Gemelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D002577 | Uterine Cervical Diseases |
| D014845 | Vulvar Diseases |