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.
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
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
Single group
Electromagnetic Guided Laparoscopy
DeviceStandard Care
Ultrasound
DeviceStandard Care
Laparoscope Images
Laparoscope images are images recorded by the laparoscope surgical device.
Ultrasound Images
Ultrasound Images are images taken by an ultrasound probe.
Electromagnetic Tracking Data
Electromagnetic tracking data is gathered from the movements made by the laparoscope surgical device during surgery. First-order statistics measures will be computed, which include Kinematics metrics such as laparoscope path length, velocity, acceleration, and jerk. We will analyze the data using a mixed model regression analysis with kinematics metrics as the response and subject as the random effect. Since the kinematics measures are time series, we will address the temporal correlation in this regression model. The fixed effects in this model will include target tissue type, CT Hansfield units, surgeon assessment of navigation difficulty, and patient's BMI. We will test for kinematics outliers by applying the Grubb's test. If there are kinematics outliers, we will try to explain them by going back to the scan and patient history.
Retrospective navigation accuracy
We are collecting data for future assessment of navigation systems, in those studies the primary out will be navigation accuracy We will analyze the data using a mixed model regression analysis with navigation accuracy as the response and subject as the random effect, as above. We will test for accuracy outliers by applying the Grubb's test and investigate accuracy outliers.
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Dana-Farber Cancer Institute
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
Siemens Medical Solutions
Collaborator
