Actively Recruiting
High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-06-12
160
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
Sponsors
F
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead Sponsor
C
Canon Medical Systems Europe B.V
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical, and vulvar cancer)
- Need for nodal excision for staging or cytoreductive reasons
- Aged 18 to 99 years
- No current lymphatic diseases
- No oncological disease in the last 5 years
- Willing and able to provide informed consent to participate
You will not qualify if you...
- Previous radiotherapy treatments
- Previous chemotherapy treatments
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
Research Team
A
Antonia Carla Testa, Professor
CONTACT
E
Elena Teodorico
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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