A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest
Recruiting · NCT05899361 · Interventional (participants receive a specific treatment) · Lead sponsor: Dana-Farber Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Brigham and Women's Hospital - Boston, Massachusetts, United States