Feasibility of a Minimally Invasive Thoracoscopic Ultrasound for Localization of Pulmonary Nodules

Completed

• Conditions: Lung Cancer
• Interventions: Other: Thoracoscopic Ultrasound

• Registration Number: NCT02665078
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The ex-vivo lung will be evaluated by XLTF-UC180 for localization of the tumor. The ultrasound probe will be put on the lung surface in several different directions to obtain the cross section with maximum diameter. The ultrasound image with size measurement of the tumor will be recorded using an ultrasound scanner (EU-Y0008, OLYMPUS MEDICALSYSTEMS CORP., Tokyo, Japan). Next, the bronchial stump of the specimen will be opened and a small sized endotracheal tube will be inserted to inflate and deflate the lung. After inflation of the lung, the tumor will be evaluated by XLTF-UC180 to see the difference in ultrasound images between deflated and inflated lung. After ultrasound evaluation, the specimen will be delivered directly to the pathology laboratory and the actual tumor size and histological diagnosis will be determined. In addition, we will evaluate the differences between US image and pathological morphology using HE slides of lung tumor. We will work together with the surgical team to confirm sign off of specimens.

Detailed Description

This is a single center clinical trial. Forty patients (sufficient for an initial evaluation) scheduled for a lobectomy or an anatomical segmental resection for malignant lung tumors will be enrolled in the study. After lung resection, the lung will be placed on a surgical table in a similar position to the in-vivo situation in the Image Guided Therapeutic operating room (GTx-OR) within Toronto General Hospital. The lung will be evaluated by XLTF-UC180 for localization of the tumor. The ultrasound probe will be put on the lung surface in several different directions to obtain the cross section with maximum diameter. The ultrasound image with size measurement of the tumor will be recorded using an ultrasound scanner (EU-Y0008, OLYMPUS MEDICALSYSTEMS CORP., Tokyo, Japan). Next, the bronchial stump of the specimen will be opened and a small sized endotracheal tube will be inserted to inflate and deflate the lung. After inflation of the lung, the tumor will be evaluated by XLTF-UC180 to see the difference in ultrasound images between deflated and inflated lung. After ultrasound evaluation, the specimen will be delivered directory to the pathology laboratory and the actual tumor size and histological diagnosis will be determined. In addition, we will evaluate the differences between US image and pathological morphology using Hemotoxylin and Eosin (HE) slides of lung tumor. We will work together with the surgical team to confirm sign off of specimens.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-05-15
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Any patients scheduled for lobectomy of anatomical segmental resection for malignant lung tumors.
• 18 Years of age and older

Exclusion Criteria

• Any patients with inability to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thoracoscopic Ultrasound	Thoracoscopic Ultrasound	Patients who undergo lobectomy or an anatomical segmental resection for malignant lung tumors will be enrolled in the study. After lung resection, the lung will be evaluated by XLTF-UC180 for localization of the tumor. The ultrasound probe will be put on the lung surface in several different directions to obtain the cross section with maximum diameter. The ultrasound image with size measurement of the tumor will be recorded using an ultrasound scanner (EU-Y0008, OLYMPUS MEDICALSYSTEMS CORP., Tokyo, Japan). After ultrasound evaluation, the specimen will be delivered directory to the pathology laboratory and the actual tumor size and histological diagnosis will be determined. In addition, we will evaluate the differences between US image and pathological morphology using HE slides of lung tumor.

Primary Outcome Measures

Name	Time	Method
Comparison of XLTF-UC180 Nodule Measurement with pathological morphology	2 Years	The primary objective of this study is to demonstrate the feasibility of thoracoscopic ultrasound for localization of pulmonary nodules in ex-vivo human lungs. We will evaluate the resected specimen using the XLTF-UC180 in the GTx-OR to determine the localization rate of the targets. Ultrasound measurement and images will be compared to the actual size of the tumor and pathological morphology using HE slides of lung tumor to determine the correlation between those variables. The tumor depth from the lung surface will be also collected to clarify the maximum depth to which the ultrasound can visualize

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada