RECRUITING

Urologic Lymphadenectomy in AMIGO

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Conditions

Urologic CancerLymph Node Metastasis

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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 involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, to simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes) in patients with urological cancer.

Official Title

Image-guided Lymphadenectomy Within Urologic Regions of Interest in AMIGO

Quick Facts

Study Start:2022-04-01
Study Completion:2025-12-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05132283

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 a CT, PET or MR examination of acceptable quality at Brigham and Women's Hospital within the prior month.
  4. * Subjects must also be scheduled to undergo lymphadenectomy for a urologic cancer within the following urologic regions of interest: Bladder, Prostate, Testicular, Kidney, Urethral, and Penile.
  5. * Subjects must also be scheduled to undergo a laparoscopic lymphadenectomy within the AMIGO OR
  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) 732-6384
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 Date2022-04-01
Study Completion Date2025-12-26

Study Record Updates

Study Start Date2022-04-01
Study Completion Date2025-12-26

Terms related to this study

Keywords Provided by Researchers

  • Urologic Cancer
  • Lymph Node Metastasis

Additional Relevant MeSH Terms

  • Urologic Cancer
  • Lymph Node Metastasis