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Imaging Protocol for Urologic Cancers

This study is testing a new way to help surgeons find lymph nodes and organs during surgery for urologic cancers (like bladder, prostate, or testicular cancer). It uses standard surgical tools, a laparoscope (a thin tube with a camera) and an ultrasound probe, but with small electromagnetic sensors attached. The goal is to see if combining these tools helps surgeons visualize and locate areas more accurately, potentially leading to better surgical outcomes and fewer complications. You might be able to join if you are 18 or older, have a confirmed or suspected urologic cancer, and are scheduled for surgery to remove lymph nodes or an organ. The study will measure how well the images and tracking data work over one year. The current status of this study is unclear.

Study design
This is a pilot study involving 10 participants. It is an interventional study, meaning participants will receive a specific intervention.
What's involved
If you participate, the electromagnetic sensors will be attached to your standard laparoscope and ultrasound probe during your scheduled surgery. The data recording is expected to take less than 10 minutes.
Compensation
Not stated in the trial record.
Follow-up
The study will collect data from the images and tracking for one year after the procedure.

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NCT05899361

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

Recruiting
NAAges 18+InterventionalDiagnostic
Dana-Farber Cancer Institute
~10 participants
Updated 2023-10-24 on ClinicalTrials.gov
What's tested:Electromagnetic Guided LaparoscopyUltrasound

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Laparoscope Images
Measured over 1 year
+2 more outcomes measured

Conditions

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

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Bladder CarcinomaKidney CarcinomaMalignant Testicular NeoplasmMalignant Ureter NeoplasmPenile CarcinomaProstate CarcinomaScrotal CarcinomaUrethral Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

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

Who to contact

Matthew Mossanen, MD
[email protected]
617-525-6348
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management
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.
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.
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
Subjects must also be scheduled to undergo a laparoscopic lymph node dissection and/or a urologic organ removal within any OR at BWH.

Exclusion

Severely impaired renal function with an EGFR \< 30 mL/min/body surface area
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
History of hypersensitivity or other contraindication to contrast media
Contraindication to general anesthesia
Pregnancy

What this trial measures

  • Laparoscope Images1 year

    Laparoscope images are images recorded by the laparoscope surgical device.

  • Ultrasound Images1 year

    Ultrasound Images are images taken by an ultrasound probe.

  • Electromagnetic Tracking Data1 year

    Electromagnetic tracking data is gathered from the movements made by the laparoscope surgical device during surgery. First-order statistics measures will be computed, which include Kinematics metrics such as laparoscope path length, velocity, acceleration, and jerk. We will analyze the data using a mixed model regression analysis with kinematics metrics as the response and subject as the random effect. Since the kinematics measures are time series, we will address the temporal correlation in this regression model. The fixed effects in this model will include target tissue type, CT Hansfield units, surgeon assessment of navigation difficulty, and patient's BMI. We will test for kinematics outliers by applying the Grubb's test. If there are kinematics outliers, we will try to explain them by going back to the scan and patient history.