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Imaging
Imaging Techniques for Urologic Cancers
N/A
Recruiting
Led By Matthew Mossanen, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be scheduled to undergo a laparoscopic lymph node dissection and/or a urologic organ removal within any OR at BWH
Subjects aged ≥ 18 years with a confirmed or suspected diagnosis of disease in urologic regions of interest, with scheduled confirmatory surgical biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial aims to improve surgical outcomes in cancer patients, reducing complications and improving accuracy of visualization and localization.
Who is the study for?
This trial is for adults over 18 with suspected or confirmed urologic cancers (like prostate, bladder, kidney, testicular, penile, urethral) who are scheduled for surgical biopsy or organ removal. They must have had a CT/PET/MR scan at Brigham and Women's Hospital within the last year and be able to undergo laparoscopic surgery.Check my eligibility
What is being tested?
The study tests if using electromagnetic tracking with laparoscope imaging and ultrasound can improve the accuracy of locating diseased areas during lymph node dissections or organ removals in urologic cancer surgeries. It aims to enhance outcomes and reduce complications.See study design
What are the potential side effects?
While not drug-related, potential side effects may include typical risks associated with laparoscopic procedures such as infection, bleeding, pain at the incision site(s), possible damage to surrounding organs/tissues and reactions to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a laparoscopic surgery to remove lymph nodes or a urologic organ at BWH.
Select...
I am over 18 and have a possible diagnosis needing a biopsy in my urinary system.
Select...
I am scheduled for surgery to remove lymph nodes or organs due to urologic cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electromagnetic Tracking Data
Laparoscope Images
Ultrasound Images
Secondary outcome measures
Retrospective navigation accuracy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Electromagnetic Guided Laparoscopy + UltrasoundExperimental Treatment2 Interventions
This trial will investigate the use of the novel imaging protocol patients who have a confirmed cancer diagnosis in any of the following urologic regions or organs: Bladder, Prostate, Testicle, Ureter, Kidney, Urethra, Penis, and Scrotum.
- This research study involves the use of a standard of care laparoscope and ultrasound probe. The laparoscope and ultrasound probe will have an electromagnetic sensor attached which will assist in the tracking of lymph nodes of interest or organs of interest. It is expected that the entire time to record the data will be less than 10 minutes. standard of care laparoscope and ultrasound probe
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound
2013
Completed Phase 1
~1950
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,967 Total Patients Enrolled
Siemens Medical SolutionsIndustry Sponsor
24 Previous Clinical Trials
3,718 Total Patients Enrolled
Matthew Mossanen, MDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a laparoscopic surgery to remove lymph nodes or a urologic organ at BWH.My kidney function is severely impaired.I am over 18 and have a possible diagnosis needing a biopsy in my urinary system.You must have had a good-quality CT, PET, or MR scan at Brigham and Women's Hospital in the past year.I cannot have general anesthesia due to health risks.I am scheduled for surgery to remove lymph nodes or organs due to urologic cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Electromagnetic Guided Laparoscopy + Ultrasound
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots available for new participants in this experiment?
"Per the clinicaltrials.gov page, this research is not presently recruiting patients; it was originally posted on August 30th 2023 and last updated June 8th 2023. Nevertheless, there are over two thousand one hundred twenty-one other trials seeking participants at present times."
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