Actively Recruiting
A Pilot Study of a Novel Imaging Protocol to Identify Lymph Nodes and Organs of Interest for Surgical Dissection in Urologic Cancers
Led by Dana-Farber Cancer Institute · Updated on 2023-10-24
10
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
S
Siemens Medical Solutions
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research evaluates a new imaging method combining electromagnetic tracking with laparoscope and ultrasound probe imaging to improve surgeries for patients with confirmed urologic cancers. These cancers may affect the bladder, prostate, testicle, kidney, urethra, penis, ureter, or scrotum. The study aims to enhance visualization and localization of affected areas during lymph node dissection or organ removal surgeries, potentially reducing complexity, complications, and improving outcomes. Participants will undergo surgeries using a standard laparoscope and ultrasound probe equipped with an electromagnetic sensor to track lymph nodes or organs of interest. This imaging protocol is expected to record data in under 10 minutes during the procedure. The study is a pilot trial involving 10 participants and is supported by Siemens Medical USA. Participants will be monitored through laparoscope and ultrasound images and electromagnetic tracking data over one year. Researchers will assess the accuracy of navigation retrospectively. The involvement includes scheduled surgeries with laparoscopic lymph node dissection and/or organ removal, supported by imaging and tracking to evaluate this novel approach. The study is led by Dana-Farber Cancer Institute and runs until December 2026.
CONDITIONS
Brief Title
A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial-related procedures
- Age 18 years or older
- Confirmed or suspected urologic disease with scheduled confirmatory surgical biopsy
- Recent CT, PET, or MR scan of acceptable quality within the past year
- Scheduled for lymph node dissection or organ removal surgery in urologic regions (Bladder, Prostate, Testicle, Ureter, Kidney, Urethra, Penis, Scrotum)
- Scheduled to undergo laparoscopic lymph node dissection and/or urologic organ removal at Brigham and Women's Hospital
You will not qualify if you...
- Severely impaired kidney function with EGFR less than 30 mL/min/body surface area
- Significant uncontrolled medical conditions that affect protocol compliance or result interpretation
- History of hypersensitivity or contraindication to contrast media
- Contraindication to general anesthesia
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and less than 10 minutes for data recording
Participants undergo a standard laparoscopic lymph node dissection and/or urologic organ removal surgery using a laparoscope and ultrasound probe equipped with an electromagnetic sensor to assist in tracking lymph nodes and organs of interest.
1 surgical visit
Duration - 1 year
Participants' laparoscope and ultrasound images, as well as electromagnetic tracking data, are collected and analyzed over 1 year to assess outcomes and navigation accuracy.
Visits as per standard follow-up care
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Matthew Mossanen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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