RecruitingNot ApplicableNCT05899361

A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest

A Pilot Study of a Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest for Surgical Dissection Within Urologic Regions of Interest.

Sponsor

Dana-Farber Cancer Institute

Enrollment

10 participants

Start Date

Aug 30, 2023

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Urologic Cancer Bladder Cancer Kidney Cancer Testicular Cancer Penile Cancer Urethral Cancer Urologic Neoplasms

Summary

This research study is a pilot clinical trial, which hypothesizes that the combination of electromagnetic tracking in conjunction with laparoscope imaging and ultrasound probe imaging will aid in reducing the complexity of both laparoscopic lymphadenectomy and/or organ removal in patients with a confirmed diagnosis of cancer in urologic regions of interest (Bladder, Prostate, Testicular, Kidney, Urethral, and Penis), by resulting in better visualization and more accurate localization of certain areas in the diseased organ or the diseased lymph node, and allowing for improved surgical and patient outcomes, fewer complications and better clinician performance.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 either of the following scans: CT, PET or MR of acceptable quality at Brigham and Women's Hospital within the past year.
Subjects must also be scheduled to undergo lymph node dissection for a urologic cancer or organ removal of any of the following urologic regions of interest: Bladder, Prostate, Testicle, Ureter, Kidney, Urethra, Penis, and Scrotum
Subjects must also be scheduled to undergo a laparoscopic lymph node dissection and/or a urologic organ removal within any OR at BWH.

Exclusion Criteria5

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