Status:

RECRUITING

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

Lead Sponsor:

Dana-Farber Cancer Institute

Collaborating Sponsors:

Siemens Medical Solutions

Conditions:

Urologic Cancer

Urologic Neoplasms

Eligibility:

All Genders

18+ years

Phase:

NA

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 redu...

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 spre...

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

Key Trial Info

Start Date :

August 30 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 25 2026

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT05899361

Start Date

August 30 2023

End Date

December 25 2026

Last Update

October 24 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

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