RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2023-08-30
Study Completion:2026-12-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05899361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management
  2. * 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.
  3. * 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.
  4. * 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
  5. * Subjects must also be scheduled to undergo a laparoscopic lymph node dissection and/or a urologic organ removal within any OR at BWH.
  1. * Severely impaired renal function with an EGFR \< 30 mL/min/body surface area
  2. * 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
  3. * History of hypersensitivity or other contraindication to contrast media
  4. * Contraindication to general anesthesia
  5. * Pregnancy

Contacts and Locations

Study Contact

Matthew Mossanen, MD
CONTACT
617-525-6348
mmossanen@bwh.harvard.edu

Principal Investigator

Matthew Mossanen, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Matthew Mossanen, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-30
Study Completion Date2026-12-25

Study Record Updates

Study Start Date2023-08-30
Study Completion Date2026-12-25

Terms related to this study

Keywords Provided by Researchers

  • Lymph Node Dissection
  • Urologic Cancer
  • Urologic Neoplasms
  • Bladder Cancer
  • Prostate Cancer
  • Testicular Cancer
  • Kidney Cancer
  • Urethral Cancer
  • Penile Cancer

Additional Relevant MeSH Terms

  • Urologic Cancer
  • Urologic Neoplasms
  • Bladder Cancer
  • Prostate Cancer
  • Testicular Cancer
  • Kidney Cancer
  • Urethral Cancer
  • Penile Cancer