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Cone-beam CT Guided Microcoil Localization of Pulmonary Nodules During Video Assisted Thoracic Surgery(VATS)

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ClinicalTrials.gov Identifier: NCT02496624
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:

The Guided Therapeutics (GTx) program at the University Health Network is a network of clinicians, scientists, and engineers focused on the development and translation of image-guided technologies focused on minimally-invasive, adaptive therapies. Technologies developed within the GTx program include a portable intra-operative cone-beam CT (in collaboration with Siemens) that has been evaluated in clinical trials for head and neck surgery. The intraoperative imaging has been integrated with tracking and navigational tools and optical imaging to provide a general "surgical dashboard" that is used to improve the accuracy of surgical resection.

A recent addition to the GTx program is the development of the GTx OR, located within the general operating room of the Toronto General Hospital. The GTx OR houses 2 complimentary advance technologies: the Siemens Zeego and the Siemens Somotom Flash CT. The dual-energy Somatom Flash provides a "gold-standard" in CT imaging, while the Zeego provides excellent 3D Cone-beam CT with robotic placement for flexible integration within the operating environment. Together, the integration of these 2 components into a single OR enables critical evaluation of the limits of CT imaging technology for surgical guidance.

This study will be conducted using solely the Cone-beam CT (Zeego) for percutaneous placement and localization of markers for resection of small pulmonary nodules during VATS.


Condition or disease Intervention/treatment Phase
Lung Cancer Other: Cone Beam CT localization and placement of microcoil Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cone-beam Computed Tomography (CT) Guided Microcoil Localization of Pulmonary Nodules During Video Assisted Thoracic Surgery(VATS)
Study Start Date : June 2015
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Lung cancer Other: Cone Beam CT localization and placement of microcoil
Cone Beam CT localization and placement of microcoil


Outcome Measures
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Primary Outcome Measures :
  1. Radiation Exposure [ Time Frame: 4 years ]
    Will determine how much radiation the patient receives via CT report

  2. Length of time to perform procedure [ Time Frame: 4 years ]
    Will time the procedure in order to determine procedure length


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any adult patient age 18 and older with lung nodules who are candidates for microcoil localization prior to VATS wedge resection

Exclusion Criteria:

  • Patients that are unable to give informed consent
  • Patients that are unable to tolerate general anesthesia
  • Patients who are pregnant or patients that believe they are pregnant
  • Patients with implantable devices susceptible to Radio Frequency (RF) fields
  • Severely obese patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02496624


Contacts
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Contact: Judy McConnell 4165817486 judy.mcconnell@uhn.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Alexandria Grindlay    416-634-7066    alexandria.grindlay@uhn.ca   
Contact: Judy McConnell    416-581-7486    judy.mcconnell@uhn.ca   
Principal Investigator: Kazuhiro Yasufuku, MD, PhD         
Sponsors and Collaborators
University Health Network, Toronto
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02496624    
Other Study ID Numbers: 14-7395
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 2021
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases