High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics

NCT06906705 | Recruiting

• 1 other identifier: 7480
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Keywords

ovarian cancer; endometrial cancer; cervical cancer; vulvar cancer; HFUS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Minimum Size Detection Limit of HFUS Imaging

  2 minutes

• Development of a Radiomic Algorithm for Lymph Node Assessment

  6 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical, and vulvar cancer)
• Need for nodal excision (staging or cytoreductive reasons)
• 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

You may not qualify if:

• Previous radiotherapy treatments
• Previous chemotherapy treatments

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Canon Medical Systems Europe B.V: collaborator

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms; Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Uterine Cervical Diseases; Vulvar Diseases

Study Officials

• Antonia Carla Testa, Professor

  Fondazione Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Carla Testa, Professor

CONTACT

0630156399; antoniacarla.testa@policlinicogemelli.it

Elena Teodorico

CONTACT

elena.teodorico@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: June 6, 2025
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-03

Locations

IT (1)