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Brief Title: Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest

A Pilot Study of a Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest for Surgical Dissection Within Urologic Regions of Interest.

INTRODUCTION

  • Org Study ID: 22-668
  • Secondary ID: N/A
  • NCT ID: NCT05899361
  • Sponsor: Dana-Farber Cancer Institute

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    August 30, 2023
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Urologic Cancer
  • Urologic Neoplasms
  • Bladder Cancer
  • Prostate Cancer
  • Testicular Cancer
  • Kidney Cancer
  • Urethral Cancer
  • Penile Cancer

ELIGIBILITY

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

OFFICIAL INFORMATION

Name: Matthew Mossanen, MD

Role: Principal Investigator

Affiliation: Brigham and Women's Hospital

Overall Contact

Name: Matthew Mossanen, MD

Phone: 617-525-6348

Email: mmossanen@bwh.harvard.edu

LOCATION

Facility Status Contact
Facility: Brigham and Women's Hospital
Boston, Massachusetts 02115
United States 		Status: Recruiting Contact: Contact
Matthew Mossanen, MD
617-732-6384
mmossanen@bwh.harvard.edu

Principal Investigator
Matthew Mossanen, MD

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