Urologic Lymphadenectomy in AMIGO

Launched by DANA-FARBER CANCER INSTITUTE · Nov 11, 2021

Keywords

ClinConnect Summary

This clinical trial, called "Urologic Lymphadenectomy in AMIGO," is studying new ways to make surgery easier for patients with urologic cancers, such as those affecting the bladder, prostate, or kidneys. The researchers are testing two advanced navigation systems that help doctors locate and remove lymph nodes more accurately during surgery. This study is currently looking for participants aged 18 and older who are scheduled to have surgery to remove lymph nodes due to cancer and have recently undergone specific imaging tests like CT or MRI.

If you or someone you know is interested in participating, you would need to provide written consent and meet certain health criteria. Participants can expect to undergo a laparoscopic lymphadenectomy, a type of minimally invasive surgery, using these new navigation systems. It's important to note that individuals with severe kidney issues, certain health conditions, or those who are pregnant may not be eligible. This trial aims to improve surgical outcomes for patients with urologic cancers by making the procedure safer and more efficient.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management
• • Subjects aged ≥ 18 years. Selected patients must have a confirmed or suspected diagnosis of disease in urologic regions of interest, with scheduled confirmatory surgical biopsy.
• • Subjects must have had a CT, PET or MR examination of acceptable quality at Brigham and Women's Hospital within the prior month.
• • Subjects must also be scheduled to undergo lymphadenectomy for a urologic cancer within the following urologic regions of interest: Bladder, Prostate, Testicular, Kidney, Urethral, and Penile.
• • Subjects must also be scheduled to undergo a laparoscopic lymphadenectomy within the AMIGO OR
• Exclusion Criteria:
• • Severely impaired renal function with an EGFR \< 30 mL/min/body surface area
• • Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, which is to be judged at the discretion of the PI
• • History of hypersensitivity or other contraindication to contrast media
• • Contraindication to general anesthesia
• • Pregnancy