Imaging Techniques for Urologic Cancers
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dana-Farber Cancer Institute
Disqualifiers: Severely impaired renal function, Pregnancy, others
No Placebo Group
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.
12345Is 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.
12367How 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.
12348Eligibility 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.
+2 more
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
+2 more
Trial 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
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
Siemens Medical SolutionsIndustry Sponsor
References
Electromagnetic tracking in image-guided laparoscopic surgery: Comparison with optical tracking and feasibility study of a combined laparoscope and laparoscopic ultrasound system. [2021]In image-guided laparoscopy, optical tracking is commonly employed, but electromagnetic (EM) systems have been proposed in the literature. In this paper, we provide a thorough comparison of EM and optical tracking systems for use in image-guided laparoscopic surgery and a feasibility study of a combined, EM-tracked laparoscope and laparoscopic ultrasound (LUS) image guidance system.
New approaches to online estimation of electromagnetic tracking errors for laparoscopic ultrasonography. [2008]In abdominal surgery, a laparoscopic ultrasound transducer is commonly used to detect lesions such as metastases. The determination and visualization of the position and orientation of its flexible tip in relation to the patient or other surgical instruments can be a great support for surgeons using the transducer intraoperatively. This difficult subject has recently received attention from the scientific community. Electromagnetic tracking systems can be applied to track the flexible tip; however, current limitations of electromagnetic tracking include its accuracy and sensibility, i.e., the magnetic field can be distorted by ferromagnetic material. This paper presents two novel methods for estimation of electromagnetic tracking error. Based on optical tracking of the laparoscope, as well as on magneto-optic and visual tracking of the transducer, these methods automatically detect in 85% of all cases whether tracking is erroneous or not, and reduce tracking errors by up to 2.5 mm.
GPS Laparoscopic Ultrasound: Embedding an Electromagnetic Sensor in a Laparoscopic Ultrasound Transducer. [2020]Tracking the location and orientation of a laparoscopic ultrasound (LUS) transducer is a prerequisite in many surgical visualization and navigation applications. Electromagnetic (EM) tracking is a preferred method to track an LUS transducer with an articulating imaging tip. The conventional approach to integrating EM tracking with LUS is to attach an EM sensor on the outer surface of the imaging tip (external setup), which is not ideal for routine clinical use. In this work, we embedded an EM sensor inside a standard LUS transducer. We found that ultrasound image quality and the four-way articulation function of the transducer were not affected by this sensor integration. Furthermore, we found that the tracking accuracy of our integrated transducer was comparable to that of the external setup. An animal study conducted using the developed transducer suggests that an internally embedded EM sensor is a clinically more viable approach, and may be the future of tracking an articulating LUS transducer.
Magneto-optical tracking of flexible laparoscopic ultrasound: model-based online detection and correction of magnetic tracking errors. [2012]Electromagnetic tracking is currently one of the most promising means of localizing flexible endoscopic instruments such as flexible laparoscopic ultrasound transducers. However, electromagnetic tracking is also susceptible to interference from ferromagnetic material, which distorts the magnetic field and leads to tracking errors. This paper presents new methods for real-time online detection and reduction of dynamic electromagnetic tracking errors when localizing a flexible laparoscopic ultrasound transducer. We use a hybrid tracking setup to combine optical tracking of the transducer shaft and electromagnetic tracking of the flexible transducer tip. A novel approach of modeling the poses of the transducer tip in relation to the transducer shaft allows us to reliably detect and significantly reduce electromagnetic tracking errors. For detecting errors of more than 5 mm, we achieved a sensitivity and specificity of 91% and 93%, respectively. Initial 3-D rms error of 6.91 mm were reduced to 3.15 mm.
Three-dimensional navigated laparoscopic ultrasonography: first experiences with a new minimally invasive diagnostic device. [2019]A three-dimensional (3D) display of diagnostic imaging methods is technically feasible and increasingly important. However, the technical integration of laparoscopic ultrasound and 3D image reconstruction has not yet been realized. For this purpose, an electromagnetic navigation system was integrated into the tip of a conventional laparoscopic ultrasound probe. This first experience with a certified prototype of a navigated 3D laparoscopic ultrasound probe is reported.
US-guided EM tracked system for HDR brachytherapy: A first in-men randomized study for whole prostate treatment. [2023]An electromagnetic tracking device (EMT) has been integrated in an HDR 3D ultrasound guidance system for prostate HDR. The aim of this study was to compare the efficiency of HDR workflows with and without EM tracking.
Multimodality Fusion with MRI, CT, and Ultrasound Contrast for Ablation of Renal Cell Carcinoma. [2021]Fusion technology with electromagnetic (EM) tracking enables navigation with multimodality feedback that lets the operator use different modalities during different parts of the image-guided procedure. This may be particularly helpful in patients with renal insufficiency undergoing kidney tumor ablation, in whom there is a desire to minimize or avoid nephrotoxic iodinated contrast exposure. EM tracking software merges and fuses different imaging modalities such as MRI, CT, and ultrasound and can also display the position of needles in real time in relation to preprocedure imaging, which may better define tumor targets than available intraoperative imaging. EM tracking was successfully used to ablate a poorly visualized renal tumor, through the combined use of CT, gadolinium-enhanced MR, and contrast-enhanced US imaging to localize the tumor.
Magneto-optic tracking of a flexible laparoscopic ultrasound transducer for laparoscope augmentation. [2019]In abdominal surgery, a laparoscopic ultrasound transducer is commonly used to detect lesions such as metastases. The determination and visualization of position and orientation of its flexible tip in relation to the patient or other surgical instruments can be of much help to (novice) surgeons utilizing the transducer intraoperatively. This difficult subject has recently been paid attention to by the scientific community . Electromagnetic tracking systems can be applied to track the flexible tip. However, the magnetic field can be distorted by ferromagnetic material. This paper presents a new method based on optical tracking of the laparoscope and magneto-optic tracking of the transducer, which is able to automatically detect field distortions. This is used for a smooth augmentation of the B-scan images of the transducer directly on the camera images in real time.