Urologic Lymphadenectomy in AMIGO
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
This research study involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, to simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes) in patients with urological cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
3D Slicer
DeviceNavigational device used during surgery to locate abnormal lymph nodes.
Monaco
DeviceNavigational device used during surgery to locate abnormal lymph nodes.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Urologic Lymphadenectomy in AMIGOExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of Patients Completing Intended Procedure (Feasibility)
The Slicer-Monaco prototype navigation platform will be used to resect enlarged and/or fluorodeoxyglucose avid lymph nodes. The successful navigational use of this platform will be considered as completed. The proportion of patients completing this intended procedure will be reported.
Time frame
One month, up to 45 days after registrationSecondary outcomes
1
Proportion of Patients with Laparoscopic Videos Recorded
During the first phase of the project on 10 patients, we will store real-time laparoscopic videos using the KARL STORZ 3D Video system that can be analyzed offline. During the second phase of 10 patients, we will provide an optional video overlay option in the navigation system. The navigation system will be similar to that used on the first 10 patients. The only difference will be that the virtual endoscopy view will be overlaid on the laparoscopy video in the 3D Slicer navigation system.
Time frame
One month, up to 45 days from registration2
Path length Kinematic Metric
The kinematic metric of path length will be computed using recorded data from the navigation system. Mean path length scores for all patients will be reported for each kinematic measure.
Time frame
One month, up to 45 days after registration3
Velocity Kinematic Metric
The kinematic metric of velocity will be computed using recorded data from the navigation system. Mean velocity scores for all patients will be reported for each kinematic measure.
Time frame
One month, up to 45 days after registration4
Acceleration Kinematic Metric
The kinematic metric of acceleration will be computed using recorded data from the navigation system. Mean acceleration scores for all patients will be reported for each kinematic measure.
Time frame
One month, up to 45 days after registrationSponsors and contacts
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Source ClinicalTrials.gov