A Novel 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.

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Cancer; Urologic Neoplasms; Prostate Cancer; Bladder Cancer; Urethral Cancer; Penile Cancer; Urologic Cancer; Testicular Cancer
• Intervention / Treatment: Device: Electromagnetic Guided Laparoscopy; Device: Ultrasound

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Mossanen, MD; Phone Number: 617-525-6348; Email: mmossanen@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Matthew Mossanen, MD; Phone Number: 617-732-6384; Email: mmossanen@bwh.harvard.edu
      • Principal Investigator: Matthew Mossanen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Electromagnetic Guided Laparoscopy + Ultrasound; This trial will investigate the use of the novel imaging protocol patients who have a confirmed cancer diagnosis in any of the following urologic regions or organs: Bladder, Prostate, Testicle, Ureter, Kidney, Urethra, Penis, and Scrotum. - 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. standard of care laparoscope and ultrasound probe

Device: Electromagnetic Guided Laparoscopy; Standard Care; Device: Ultrasound; Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laparoscope Images	Laparoscope images are images recorded by the laparoscope surgical device.	1 year
Ultrasound Images	Ultrasound Images are images taken by an ultrasound probe.	1 year
Electromagnetic Tracking Data	Electromagnetic tracking data is gathered from the movements made by the laparoscope surgical device during surgery. First-order statistics measures will be computed, which include Kinematics metrics such as laparoscope path length, velocity, acceleration, and jerk. We will analyze the data using a mixed model regression analysis with kinematics metrics as the response and subject as the random effect. Since the kinematics measures are time series, we will address the temporal correlation in this regression model. The fixed effects in this model will include target tissue type, CT Hansfield units, surgeon assessment of navigation difficulty, and patient's BMI. We will test for kinematics outliers by applying the Grubb's test. If there are kinematics outliers, we will try to explain them by going back to the scan and patient history.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retrospective navigation accuracy	We are collecting data for future assessment of navigation systems, in those studies the primary out will be navigation accuracy We will analyze the data using a mixed model regression analysis with navigation accuracy as the response and subject as the random effect, as above. We will test for accuracy outliers by applying the Grubb's test and investigate accuracy outliers.	1 year

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Siemens Medical Solutions
• Investigators: Principal Investigator: Matthew Mossanen, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): August 26, 2025
• Study Completion (Estimated): December 25, 2026

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Prostate Cancer; Bladder Cancer; Kidney Cancer; Lymph Node Dissection; Urologic Neoplasms; Testicular Cancer; Urethral Cancer; Urologic Cancer; Penile Cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Prostatic Diseases; Urethral Diseases; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Kidney Neoplasms; Carcinoma, Renal Cell; Testicular Neoplasms; Prostatic Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urethral Neoplasms; Penile Neoplasms
• Other Study ID Numbers: 22-668

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes