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

NCT02665078 | Completed

• 1 other identifier: 13-7111
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of XLTF-UC180 Nodule Measurement with pathological morphology

  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

  2 Years

Study Arms (1)

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.

Other: Thoracoscopic Ultrasound

Interventions

Thoracoscopic Ultrasound OTHER

We will evaluate the resected specimen using the XLTF-UC180 in the operating room (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.

Thoracoscopic Ultrasound

Eligibility Criteria

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

Study Population

Any patients scheduled for lobectomy of anatomical segmental resection for malignant lung tumors.

You may qualify if:

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

You may not qualify if:

• Any patients with inability to give informed consent

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 Officials

• Kazuhiro Yasufuku, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: January 27, 2016
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)