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

NCT02496624 | Completed

• 1 other identifier: 14-7395
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Radiation Exposure

  Will determine how much radiation the patient receives via CT report

  4 years

• Length of time to perform procedure

  Will time the procedure in order to determine procedure length

  4 years

Study Arms (1)

Lung cancer

OTHER

Other: Cone Beam CT localization and placement of microcoil

Interventions

Cone Beam CT localization and placement of microcoil OTHER

Cone Beam CT localization and placement of microcoil

Lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 14, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CA (1)