Clinical trial NCT05132283: Urologic Lymphadenectomy in AMIGO
Official title: Image-guided Lymphadenectomy Within Urologic Regions of Interest in AMIGO
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urologic Cancer
Lymph Node Metastasis
Keywords: Urologic Cancer
Lymph Node Metastasis
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: This research study involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, which will simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes).

The U.S. Food and Drug Administration (FDA) has not approved the navigation systems (3D Slicer and Monaco) as a treatment for any disease.

In this research study, our hypothesis is that the use of the navigation systems (3D Slicer and the Siemens Monaco system) may simplify the complexity of laparoscopic lymphadenectomy (The procedure in which a small incision is made in the lower abdomen to reach the lymph nodes) in regions of urologic interest, by resulting in better visualization and more accurate localization of the diseased lymph node and allowing for improved surgical and patient outcomes, fewer complications, and better clinician performance.

The long-term goal of our program is to demonstrate that the navigation system (3D Slicer and the Siemens Monaco system) increase the efficiency and reduce the morbidity or the likelihood of any medical problems associated with the resection or removal of radiologically defined lesions, within urologic regions of interest, associated with any type of urologic cancer. The first clinical application of the system will be in resecting radiologically positive lymph nodes displayed by CT or FDG PET (an imaging test used to identify lymphomas and other cancers) in the Advanced Multimodality Image-Guided Operating (AMIGO) Suite at Brigham and Women's Hospital (BWH).

The navigation system has been used with similar protocols, specifically 5 parathyroid surgeries, 13 tracked endoscopic ultrasound (minimally invasive procedure to assess digestive and lung diseases) and over 30 tracked colonoscopy experiments (exam used to detect changes or abnormalities in the large intestine (colon) and rectum) on human subjects at BWH with no difficulties or reportable incidents.

It will take you up to 4 weeks to complete this study. During that time you will have two study visits and one standard of care follow-up visit.

The research study procedures include: screening for eligibility and study treatment including evaluations and standard of care follow-up visits.

It is expected that about 20 people will take part in this research study.

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

Primary outcomes:
measure: Proportion of Patients Completing Intended Procedure (Feasibility)
timeFrame: One month, up to 45 days after registration
Secondary outcomes:
measure: Proportion of Patients with Laparoscopic Videos Recorded
timeFrame: One month, up to 45 days from registration
measure: Path length Kinematic Metric
timeFrame: One month, up to 45 days after registration
measure: Velocity Kinematic Metric
timeFrame: One month, up to 45 days after registration
measure: Acceleration Kinematic Metric
timeFrame: One month, up to 45 days after registration
measure: Jerk Kinematic Metric
timeFrame: One month, up to 45 days after registration
measure: Mental/Physical/Temporal Demand on Physician
timeFrame: One month, up to 45 days after registration
measure: Mean absolute difference in distance from Instruments to Organs
timeFrame: One month, up to 45 days after registration
measure: Further, the pathology of the lymph node resected using the navigation system will be compared to the other lymph nodes resected in urologic regions of interest.
timeFrame: One month, up to 45 days after registration
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Matthew Mossanen, MD
role: PRINCIPAL_INVESTIGATOR
References: