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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Contact Information
Primary
Antonia Carla Testa, Professor
antoniacarla.testa@policlinicogemelli.it
0630156399
Backup
Elena Teodorico
elena.teodorico@guest.policlinicogemelli.it
Time Frame
Start Date: 2025-06-06
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 160
Related Therapeutic Areas
Sponsors
Collaborators: Canon Medical Systems Europe B.V
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov