High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 26, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new method called high-frequency ultrasound to help doctors assess lymph nodes during surgery for gynecological cancers, such as ovarian, endometrial, cervical, and vulvar cancer. Lymph nodes are small structures that can show if cancer has spread, and understanding their status is very important for determining the best treatment. Traditionally, doctors have removed many lymph nodes to check for cancer, but this can lead to serious complications and is often unnecessary since most lymph nodes do not have cancer. This trial aims to see if using ultrasound during surgery can make the process easier and safer for patients.
To be eligible for the trial, women aged 18 to 99 who are scheduled for surgery to treat gynecological cancers and need lymph node removal may participate. Participants will need to agree to join the study and provide consent. Importantly, those who have had recent cancer treatment, such as chemotherapy or radiotherapy, are not eligible. If you join the study, you can expect to undergo the ultrasound assessment during your surgery, which could help reduce risks and improve how your treatment is planned. The trial is not yet recruiting participants, but it represents a promising step toward safer surgical options for women facing gynecological cancer.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • Previous radiotherapy treatments
- • Previous chemotherapy treatments
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
Patients applied
Trial Officials
Antonia Carla Testa, Professor
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported