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Procedure

Surgical Guidance Technology for Urologic Cancer Surgery

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 lymphadenectomy for a urologic cancer within the urologic regions of interest: Bladder, Prostate, Testicular, Kidney, Urethral, and Penile

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 one month, up to 45 days from registration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different ways to guide surgeons during cancer surgery to remove lymph nodes.

Who is the study for?

This trial is for adults over 18 with confirmed or suspected urologic cancers (bladder, prostate, testicular, kidney, urethral, penile) who need lymph node removal surgery. They must have had a recent quality imaging scan at Brigham and Women's Hospital and be able to undergo general anesthesia without significant health risks.

What is being tested?

The study compares two navigation systems: the 3D Slicer-based system and the Siemens Monaco system. These are used during laparoscopic lymphadenectomy (lymph node removal surgery) to see if they can make this complex procedure simpler for patients with urological cancer.

What are the potential side effects?

While specific side effects aren't listed for the navigation systems being tested, typical risks of laparoscopic lymphadenectomy may include bleeding, infection, pain at incision sites, possible damage to nearby organs or tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a lymph node removal surgery for cancer in my bladder, prostate, testicle, kidney, urethra, or penis.

Select...

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

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I am scheduled for a laparoscopic lymph node removal in the AMIGO operating room.

Exclusion Criteria

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

Select...

My kidney function is severely impaired.

Select...

I cannot have general anesthesia due to health risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month, up to 45 days from registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one month, up to 45 days from registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and one month, up to 45 days from registration for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of Patients Completing Intended Procedure (Feasibility)

Secondary study objectives

Acceleration Kinematic Metric

Further, the pathology of the lymph node resected using the navigation system will be compared to the other lymph nodes resected in urologic regions of interest.

Jerk Kinematic Metric

+5 more

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: Urologic Lymphadenectomy in AMIGOExperimental Treatment2 Interventions

Participants will undergo Lymphadenectomy per standard of care with the navigation systems (3D Slicer and Monaco) used to locate the abnormal lymph node(s).

0 / 5Eligibility criteria met