Urologic Lymphadenectomy in AMIGO

NCT05132283 | Recruiting DMC FDA Device

• 1 other identifier: 21-372
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Urologic Cancer; Lymph Node Metastasis

Keywords

Urologic Cancer; Lymph Node Metastasis

Outcome Measures

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.

  One month, up to 45 days after registration

Secondary Outcomes (8)

• Proportion of Patients with Laparoscopic Videos Recorded

  One month, up to 45 days from registration

• Path length Kinematic Metric

  One month, up to 45 days after registration

• Velocity Kinematic Metric

  One month, up to 45 days after registration

• Acceleration Kinematic Metric

  One month, up to 45 days after registration

• Jerk Kinematic Metric

  One month, up to 45 days after registration

Study Arms (1)

Urologic Lymphadenectomy in AMIGO

EXPERIMENTAL

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

Device: 3D Slicer; Device: Monaco

Interventions

3D Slicer DEVICE

Navigational device used during surgery to locate abnormal lymph nodes.

Urologic Lymphadenectomy in AMIGO

Monaco DEVICE

Navigational device used during surgery to locate abnormal lymph nodes.

Urologic Lymphadenectomy in AMIGO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Urologic Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Mossanen, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Mossanen, MD

CONTACT

(617) 732-6384; mmossanen@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologic Surgeon

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 24, 2021
• Study Start: April 1, 2022
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)