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

NCT ID: NCT05899361

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2026-12-25

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Electromagnetic Guided Laparoscopy

Intervention Type: DEVICE

Standard Care

Ultrasound

Intervention Type: DEVICE

Standard Care

Interventions

Electromagnetic Guided Laparoscopy

Standard Care

Intervention Type: DEVICE

Ultrasound

Standard Care

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siemens Medical Solutions

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Matthew Mossanen, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Mossanen, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew Mossanen, MD

Role: CONTACT

mmossanen@bwh.harvard.edu

617-525-6348

Facility Contacts

Matthew Mossanen, MD

Role: primary

mmossanen@bwh.harvard.edu

617-732-6384

Other Identifiers

22-668

Identifier Type: -

Identifier Source: org_study_id