A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest

Trial Title: A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest

NCT ID: NCT05899361

Condition: Urologic Cancer
Urologic Neoplasms
Bladder Cancer
Prostate Cancer
Testicular Cancer
Kidney Cancer
Urethral Cancer
Penile Cancer

Conditions: Official terms:
Prostatic Neoplasms
Urinary Bladder Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Urethral Neoplasms
Testicular Neoplasms
Penile Neoplasms
Urologic Neoplasms

Conditions: Keywords:
Lymph Node Dissection
Urologic Cancer
Urologic Neoplasms
Bladder Cancer
Prostate Cancer
Testicular Cancer
Kidney Cancer
Urethral Cancer
Penile Cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Electromagnetic Guided Laparoscopy
Description: Standard Care
Arm group label: Electromagnetic Guided Laparoscopy + Ultrasound

Intervention type: Device
Intervention name: Ultrasound
Description: Standard Care
Arm group label: Electromagnetic Guided Laparoscopy + Ultrasound

Summary: 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.

Detailed description: Participants in this research study, may or may not have a tumor within a urologic region of interest such as the bladder, prostate, testicle, kidney, urethra, and penis which may or may not have spread to a lymph node and have been scheduled to undergo a lymph node dissection procedure and/or organ removal surgery within one of the previously mentioned urologic regions of interest concerning for urologic cancer. This research study involves the use of a standard of care laparoscope and ultrasound probe. The laparoscope and ultrasound probe will have an electromagnetic sensor attached which will assist in the tracking of lymph nodes of interest or organs of interest. It is expected that the entire time to record the data will be less than 10 minutes. A total of 10 people will take part in this research study This study is supported by Siemens Medical USA.

Criteria for 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 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 - Subjects must also be scheduled to undergo a laparoscopic lymph node dissection and/or a urologic organ removal within any OR at BWH. 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Brigham and Women's Hospital

Address:
City: Boston
Zip: 02115
Country: United States

Status: Recruiting

Contact:
Last name: Matthew Mossanen, MD

Phone: 617-732-6384
Email: mmossanen@bwh.harvard.edu

Investigator:
Last name: Matthew Mossanen, MD
Email: Principal Investigator

Start date: August 30, 2023

Completion date: December 25, 2026

Lead sponsor:
Agency: Dana-Farber Cancer Institute
Agency class: Other

Collaborator:
Agency: Siemens Medical Solutions
Agency class: Industry

Source: Dana-Farber Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05899361