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

Last updated: October 23, 2023
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Cancer

Prostate Cancer

Urologic Cancer

Treatment

Ultrasound

Electromagnetic Guided Laparoscopy

Clinical Study ID

NCT05899361
22-668
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed written informed consent before any trial-related procedure is undertaken thatis not part of the standard patient management
  • Subjects aged ≥ 18 years. Selected patients must have a confirmed or suspecteddiagnosis of disease in urologic regions of interest, with scheduled confirmatorysurgical biopsy.
  • Subjects must have had either of the following scans: CT, PET or MR of acceptablequality at Brigham and Women's Hospital within the past year.
  • Subjects must also be scheduled to undergo lymph node dissection for a urologic canceror 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/ora urologic organ removal within any OR at BWH.

Exclusion

Exclusion Criteria:

  • Severely impaired renal function with an EGFR < 30 mL/min/body surface area
  • Evidence of any significant, uncontrolled comorbid condition that could affectcompliance with the protocol or interpretation of the results, which is to be judgedat the discretion of the PI
  • History of hypersensitivity or other contraindication to contrast media
  • Contraindication to general anesthesia
  • Pregnancy

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Ultrasound
Phase:
Study Start date:
August 30, 2023
Estimated Completion Date:
December 25, 2026

Study 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.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

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