NCT06906705 High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics
| NCT ID | NCT06906705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Gynecologic Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-06-06 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2025-06-06 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Antonia Carla Testa, Professor
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli
Frequently Asked Questions
Who can join the NCT06906705 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Gynecologic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06906705 currently recruiting?
Yes, NCT06906705 is actively recruiting participants. Contact the research team at antoniacarla.testa@policlinicogemelli.it for enrollment information.
Where is the NCT06906705 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06906705 clinical trial?
NCT06906705 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Antonia Carla Testa, Professor at Fondazione Policlinico Universitario Agostino Gemelli. The trial plans to enroll 160 participants.
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