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.
Dana-Farber Cancer Institute
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.
Description
Participants in this research study, may or may not have a tumor within a urologic region of interest such as the bladder, prostate, testicle, kidney, urethra, and penis which may or may not have spread to a lymph node and have been scheduled to undergo a lymph node dissection procedure and/or organ removal surgery within one of the previously mentioned urologic regions of interest concerning for urologic cancer. This research study involves the use of a standard of care laparoscope and ultrasound probe. The laparoscope and ultrasound probe will have an electromagnetic sensor attached which w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 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 th…
Interventions
- DeviceElectromagnetic Guided Laparoscopy
Standard Care
- DeviceUltrasound
Standard Care
Location
- Brigham and Women's HospitalBoston, Massachusetts