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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT02496624
Collaborator
(none)
40
1
1
84
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cone Beam CT localization and placement of microcoil
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Lung cancer

Other: Cone Beam CT localization and placement of microcoil
Cone Beam CT localization and placement of microcoil

Outcome Measures

Primary Outcome Measures

  1. Radiation Exposure [4 years]

    Will determine how much radiation the patient receives via CT report

  2. Length of time to perform procedure [4 years]

    Will time the procedure in order to determine procedure length

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University Health Network Toronto Ontario Canada M5G 2C4

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02496624
Other Study ID Numbers:
  • 14-7395
First Posted:
Jul 14, 2015
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021