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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02496624
• Other study ID #: 14-7395
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: University Health Network, Toronto
• Contact: Judy McConnell
• Phone: 4165817486
• Email: judy.mcconnell[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation Exposure	Will determine how much radiation the patient receives via CT report	4 years
Primary	Length of time to perform procedure	Will time the procedure in order to determine procedure length	4 years