Back to resultsCone-beam CT Guided Microcoil Localization of Pulmonary Nodules During Video Assisted Thoracic Surgery(VATS)
Primary Purpose
Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cone Beam CT localization and placement of microcoil
Sponsored by
About this trial
This is an interventional other trial for Lung Cancer
Eligibility 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
Sites / Locations
- University Health NetworkRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lung cancer
Arm Description
Outcomes
Primary Outcome Measures
Radiation Exposure
Will determine how much radiation the patient receives via CT report
Length of time to perform procedure
Will time the procedure in order to determine procedure length
Secondary Outcome Measures
Full Information
NCT ID
NCT02496624
First Posted
July 6, 2015
Last Updated
October 31, 2022
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02496624
Brief Title
Cone-beam CT Guided Microcoil Localization of Pulmonary Nodules During Video Assisted Thoracic Surgery(VATS)
Official Title
Cone-beam Computed Tomography (CT) Guided Microcoil Localization of Pulmonary Nodules During Video Assisted Thoracic Surgery(VATS)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lung cancer
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Cone Beam CT localization and placement of microcoil
Intervention Description
Cone Beam CT localization and placement of microcoil
Primary Outcome Measure Information:
Title
Radiation Exposure
Description
Will determine how much radiation the patient receives via CT report
Time Frame
4 years
Title
Length of time to perform procedure
Description
Will time the procedure in order to determine procedure length
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judy McConnell
Phone
4165817486
Email
judy.mcconnell@uhn.ca
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandria Grindlay
Phone
416-634-7066
Email
alexandria.grindlay@uhn.ca
First Name & Middle Initial & Last Name & Degree
Judy McConnell
Phone
416-581-7486
Email
judy.mcconnell@uhn.ca
First Name & Middle Initial & Last Name & Degree
Kazuhiro Yasufuku, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Cone-beam CT Guided Microcoil Localization of Pulmonary Nodules During Video Assisted Thoracic Surgery(VATS)
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