Urologic Lymphadenectomy in AMIGO

NCT ID: NCT05132283

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-12-26

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.

Conditions

Urologic Cancer; Lymph Node Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Urologic Lymphadenectomy in AMIGO

Participants will undergo Lymphadenectomy per standard of care with the navigation systems (3D Slicer and Monaco) used to locate the abnormal lymph node(s).

Group Type: EXPERIMENTAL

3D Slicer

Intervention Type: DEVICE

Navigational device used during surgery to locate abnormal lymph nodes.

Monaco

Intervention Type: DEVICE

Navigational device used during surgery to locate abnormal lymph nodes.

Interventions

3D Slicer

Navigational device used during surgery to locate abnormal lymph nodes.

Intervention Type: DEVICE

Monaco

Navigational device used during surgery to locate abnormal lymph nodes.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Matthew Mossanen, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Mossanen, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew Mossanen, MD

Role: CONTACT

mmossanen@bwh.harvard.edu

(617) 732-6384

Facility Contacts

Matthew Mossanen, MD

Role: primary

mmossanen@bwh.harvard.edu

617-732-6384

Other Identifiers

21-372

Identifier Type: -

Identifier Source: org_study_id