Actively Recruiting

Age: 18Years - 99Years
FEMALE
NCT06906705

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

Age: 18Years - 99Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Previous radiotherapy treatments
  • Previous chemotherapy treatments

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

Actively Recruiting

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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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