New imaging method to improve surgery for urologic cancers
A Pilot Study of a Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest for Surgical Dissection Within Urologic Regions of Interest.
This study is testing a new imaging method to help doctors see better during surgery for patients with urologic cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05899361 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial investigates a novel imaging protocol that combines electromagnetic tracking with laparoscopic and ultrasound imaging to enhance the surgical process for patients with urologic cancers. The aim is to improve visualization and localization of affected lymph nodes and organs during procedures such as lymph node dissection and organ removal. Participants will include individuals with confirmed or suspected urologic cancers who are scheduled for surgery. The study will involve the use of standard laparoscopic tools equipped with electromagnetic sensors to assist in tracking. A total of 10 participants will be enrolled in this trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed or suspected diagnosis of urologic cancer who are scheduled for lymph node dissection or organ removal.
Not a fit: Patients with severely impaired renal function or significant uncontrolled comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes, reduced complications, and enhanced clinician performance in treating urologic cancers.
How similar studies have performed: While this approach is innovative, similar studies utilizing advanced imaging techniques have shown promise in improving surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Matthew Mossanen, MD — Brigham and Women's Hospital
- Study coordinator: Matthew Mossanen, MD
- Email: mmossanen@bwh.harvard.edu
- Phone: 617-525-6348
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.