Using ultrasound to assess gynecologic cancer before surgery
Accuracy of Ultrasound Scan in Patients Undergoing Pelvic Exenteration and Laterally Extended Pelvic Resection
This study is testing if ultrasound scans can help doctors better diagnose and understand recurrent gynecologic cancers in patients who are about to have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 85 (estimated) |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06278610 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of ultrasound scans in diagnosing and staging recurrent gynecologic cancers in patients scheduled for pelvic exenteration or laterally extended pelvic resection. Patients will undergo ultrasound examinations prior to surgery, and the findings will be compared to final histology results to determine the accuracy of ultrasound in this context. The study will utilize high-end ultrasound equipment and will be conducted by specialists in gynecologic oncology. The goal is to improve diagnostic accuracy and potentially influence surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically-proven recurrent or persistent gynecological cancer who are scheduled for pelvic exenteration or laterally extended pelvic resection.
Not a fit: Patients who have undergone radical hysterectomy without lateral resection or those requiring only rectal resection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing recurrent gynecologic cancers, leading to better surgical planning and outcomes for patients.
How similar studies have performed: While ultrasound has shown promise in primary settings for gynecologic cancers, its application in recurrent cases, particularly for laterally-extended pelvic recurrences, is less explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All consecutive patients with histologically-proven recurrent or persistent gynecological cancer who are planned to undergo pelvic exenteration or laterally extended pelvic resection, both with curative and with palliative intent. * Anterior/total pelvic exenteration * Laterally extended endopelvic resection (LEER) * Laterally extended pelvic resection (LEPR) is defined as an en bloc lateral resection of a pelvic tumor involving sidewall muscle, and/or bone, and/or major nerve, and/or major vascular structure * With or without stoma formation Exclusion Criteria: * Radical hysterectomy without lateral resection * Rectal resection only (posterior exenteration)
Where this trial is running
Roma
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Antonia Carla Testa, Prof — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Antonia Carla Testa, Prof
- Email: antoniacarla.testa@policlinicogemelli.it
- Phone: 0630156399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.