NCT05899361 A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest
| NCT ID | NCT05899361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Urologic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-08-30 |
| Primary Completion | 2025-08-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2023-08-30 with a primary completion date of 2025-08-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Matthew Mossanen, MD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT05899361 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urologic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05899361 currently recruiting?
Yes, NCT05899361 is actively recruiting participants. Contact the research team at mmossanen@bwh.harvard.edu for enrollment information.
Where is the NCT05899361 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05899361 clinical trial?
NCT05899361 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Matthew Mossanen, MD at Brigham and Women's Hospital. The trial plans to enroll 10 participants.
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