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

NCT ID: NCT02496624

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Lung cancer

Group Type OTHER

Cone Beam CT localization and placement of microcoil

Intervention Type OTHER

Cone Beam CT localization and placement of microcoil

Interventions

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Cone Beam CT localization and placement of microcoil

Cone Beam CT localization and placement of microcoil

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Judy McConnell

Role: CONTACT

4165817486

Facility Contacts

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Alexandria Grindlay

Role: primary

416-634-7066

Judy McConnell

Role: backup

416-581-7486

Other Identifiers

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14-7395

Identifier Type: -

Identifier Source: org_study_id

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