Imaging Techniques for Urologic Cancers

Overseen By Matthew Mossanen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Severely impaired renal function, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is a pilot clinical trial, which hypothesizes that the combination of electromagnetic tracking in conjunction with laparoscope imaging and ultrasound probe imaging will aid in reducing the complexity of both laparoscopic lymphadenectomy and/or organ removal in patients with a confirmed diagnosis of cancer in urologic regions of interest (Bladder, Prostate, Testicular, Kidney, Urethral, and Penis), by resulting in better visualization and more accurate localization of certain areas in the diseased organ or the diseased lymph node, and allowing for improved surgical and patient outcomes, fewer complications and better clinician performance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Electromagnetic Guided Laparoscopy for urologic cancers?

Research shows that electromagnetic tracking systems, when used in laparoscopic ultrasound, can accurately track the position and orientation of surgical instruments, which helps surgeons during operations. Studies have demonstrated that integrating electromagnetic sensors into laparoscopic ultrasound devices maintains image quality and improves tracking accuracy, making it a promising approach for surgical navigation. ^{1 2 3 4 5}

Is electromagnetic tracking in laparoscopic and ultrasound procedures safe for humans?

Electromagnetic tracking systems have been used in various medical procedures, including laparoscopic and ultrasound surgeries, and studies suggest they are generally safe. They have been successfully integrated into surgical tools without affecting image quality or functionality, and animal studies indicate they are viable for clinical use. ^{1 2 3 6 7}

How is the treatment Electromagnetic Guided Laparoscopy with Ultrasound different from other treatments for urologic cancers?

This treatment is unique because it combines electromagnetic tracking with laparoscopic ultrasound to improve the accuracy and visualization during surgery. Unlike traditional methods, it uses an embedded electromagnetic sensor to track the ultrasound transducer's position and orientation, which helps surgeons navigate more precisely, even in challenging conditions. ^{1 2 3 4 8}

Research Team

Matthew Mossanen, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

Inclusion Criteria

Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management

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

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

Exclusion Criteria

My kidney function is severely impaired.

Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, to be judged at the discretion of the PI

History of hypersensitivity or other contraindication to contrast media

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a lymph node dissection procedure and/or organ removal surgery using a novel imaging protocol with electromagnetic tracking, laparoscope, and ultrasound probe.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure, with data collection for navigation accuracy and imaging outcomes.

1 year

Treatment Details

Interventions

• Electromagnetic Guided Laparoscopy
• Ultrasound

Trial Overview 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.

Participant Groups

Group I: Electromagnetic Guided Laparoscopy + Ultrasound Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Siemens Medical Solutions

Industry Sponsor

Trials

26

Recruited

6,100+

Findings from Research

Optical tracking systems for laparoscopic surgery showed less jitter and better consistency in orientation measurements compared to electromagnetic (EM) trackers, but their accuracy decreased significantly over longer distances, making EM trackers more stable at greater ranges.

The study suggests that using an EM-tracked laparoscope is preferable due to its consistent performance, especially when the sensor is placed at the proximal end, despite the optical trackers performing better in close-range measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromagnetic tracking in image-guided laparoscopic surgery: Comparison with optical tracking and feasibility study of a combined laparoscope and laparoscopic ultrasound system. Xiao, G., Bonmati, E., Thompson, S., et al.[2021]

The study introduces two innovative methods for improving the accuracy of electromagnetic tracking systems used in laparoscopic ultrasound, which can help surgeons better visualize the position of the ultrasound transducer during abdominal surgery.

These methods successfully detect tracking errors in 85% of cases and reduce errors by up to 2.5 mm, enhancing the reliability of the tracking system despite challenges posed by magnetic field distortions from ferromagnetic materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New approaches to online estimation of electromagnetic tracking errors for laparoscopic ultrasonography. Feuerstein, M., Reichl, T., Vogel, J., et al.[2008]

Embedding an electromagnetic (EM) sensor inside a laparoscopic ultrasound (LUS) transducer does not compromise ultrasound image quality or the transducer's articulation capabilities, making it a practical solution for clinical use.

The tracking accuracy of the internally embedded EM sensor is comparable to traditional external setups, suggesting that this method could enhance the effectiveness of surgical navigation without affecting performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GPS Laparoscopic Ultrasound: Embedding an Electromagnetic Sensor in a Laparoscopic Ultrasound Transducer. Liu, X., Kane, TD., Shekhar, R.[2020]

The study introduces a hybrid tracking system that combines optical and electromagnetic tracking to improve the localization of flexible laparoscopic ultrasound transducers, addressing the issue of electromagnetic interference from ferromagnetic materials.

By modeling the relationship between the transducer tip and shaft, the method significantly reduced tracking errors from an initial 6.91 mm to 3.15 mm, achieving high sensitivity (91%) and specificity (93%) in detecting errors over 5 mm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magneto-optical tracking of flexible laparoscopic ultrasound: model-based online detection and correction of magnetic tracking errors. Feuerstein, M., Reichl, T., Vogel, J., et al.[2012]

The integration of an electromagnetic navigation system into a laparoscopic ultrasound probe allows for accurate 3D imaging of liver tumors, enhancing the definition of tumor location and margins during laparoscopic procedures.

Compared to the gold standard 3D CT scan, navigated 3D laparoscopic ultrasound is slightly less accurate in volumetric assessment but outperforms transcutaneous ultrasound, indicating its potential to improve surgical planning and interventions for liver pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional navigated laparoscopic ultrasonography: first experiences with a new minimally invasive diagnostic device. Harms, J., Feussner, H., Baumgartner, M., et al.[2019]

The integration of an electromagnetic tracking device (EMT) in HDR prostate procedures significantly reduced overall operation room time by about 20%, with median times of 63 minutes for EMT compared to 79 minutes for the Oncentra prostate system (OCP).

EMT improved the efficiency of catheter reconstruction, with 62% of cases requiring no or few manual corrections, although challenges such as interferences and stiffness of the stylet were noted, indicating a need for further refinement in the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

US-guided EM tracked system for HDR brachytherapy: A first in-men randomized study for whole prostate treatment. Lavallee, MC., Cantin, A., Aubin, S., et al.[2023]

Electromagnetic (EM) tracking technology enhances image-guided procedures by allowing the use of multiple imaging modalities, which is particularly beneficial for patients with renal insufficiency who need to avoid nephrotoxic iodinated contrast.

In a successful case, EM tracking was utilized to ablate a poorly visualized renal tumor by integrating CT, gadolinium-enhanced MRI, and contrast-enhanced ultrasound, improving tumor localization and targeting during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodality Fusion with MRI, CT, and Ultrasound Contrast for Ablation of Renal Cell Carcinoma. Amalou, H., Wood, BJ.[2021]

A new optical and magneto-optic tracking method for laparoscopic ultrasound transducers improves the accuracy of detecting lesions during abdominal surgery by automatically compensating for magnetic field distortions.

This real-time tracking system enhances the visualization of the transducer's position and orientation, which can significantly assist novice surgeons in performing procedures more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magneto-optic tracking of a flexible laparoscopic ultrasound transducer for laparoscope augmentation. Feuerstein, M., Reichl, T., Vogel, J., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Electromagnetic tracking in image-guided laparoscopic surgery: Comparison with optical tracking and feasibility study of a combined laparoscope and laparoscopic ultrasound system. [2021]

2. England pubmed.ncbi.nlm.nih.gov

New approaches to online estimation of electromagnetic tracking errors for laparoscopic ultrasonography. [2008]

3. England pubmed.ncbi.nlm.nih.gov

GPS Laparoscopic Ultrasound: Embedding an Electromagnetic Sensor in a Laparoscopic Ultrasound Transducer. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Magneto-optical tracking of flexible laparoscopic ultrasound: model-based online detection and correction of magnetic tracking errors. [2012]

5. Germany pubmed.ncbi.nlm.nih.gov

Three-dimensional navigated laparoscopic ultrasonography: first experiences with a new minimally invasive diagnostic device. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

US-guided EM tracked system for HDR brachytherapy: A first in-men randomized study for whole prostate treatment. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Multimodality Fusion with MRI, CT, and Ultrasound Contrast for Ablation of Renal Cell Carcinoma. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Magneto-optic tracking of a flexible laparoscopic ultrasound transducer for laparoscope augmentation. [2019]