Recruiting

Imaging Protocol

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT05899361

Conditions

Urologic Cancer

Urologic Neoplasms

Bladder Cancer

Prostate Cancer

Testicular Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electromagnetic Guided Laparoscopy

Ultrasound

Study Details

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.

Conditions

Urologic Cancer

Urologic Neoplasms

Bladder Cancer

Prostate Cancer

Testicular Cancer

Study ID

NCT05899361

Start date

Aug 30, 2023

Status verified date

Oct, 2023

Completion date

Dec 25, 2026

Anticipated

Primary completion date

Aug 26, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

Interventions

Electromagnetic Guided Laparoscopy

Standard Care

Ultrasound

Standard Care

Primary outcome measure

  • Laparoscope Images [ Time Frame: 1 year ]
  • Ultrasound Images [ Time Frame: 1 year ]
  • Electromagnetic Tracking Data [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Matthew Mossanen, MD

617-525-6348mmossanen@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Matthew Mossanen, MD

617-732-6384mmossanen@bwh.harvard.edu

Principal Investigator:

Matthew Mossanen, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Oct 24, 2023

Last verified

Oct, 2023

Keywords

  • Lymph Node Dissection
  • Urologic Cancer
  • Urologic Neoplasms
  • Bladder Cancer
  • Prostate Cancer
  • Testicular Cancer
  • Kidney Cancer
  • Urethral Cancer
  • Penile Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2023-10-24.