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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

Must not have

Severely impaired renal function with an EGFR < 30 mL/min/body surface area

Contraindication to general anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am scheduled for a laparoscopic surgery to remove lymph nodes or a urologic organ at BWH.

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I am over 18 and have a possible diagnosis needing a biopsy in my urinary system.

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I am scheduled for surgery to remove lymph nodes or organs due to urologic cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is severely impaired.

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I cannot have general anesthesia due to health risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Electromagnetic Tracking Data

Laparoscope Images

Ultrasound Images

Secondary study objectives

Retrospective navigation accuracy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~4090

0 / 5Eligibility criteria met