Clinical trial NCT02665078: Feasibility of a Minimally Invasive Thoracoscopic Ultrasound for Localization of Pulmonary Nodules
Official title: Feasibility of a Minimally Invasive Thoracoscopic Ultrasound for Localization of Pulmonary Nodules Using Resected Human Lungs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients scheduled for lobectomy of anatomical segmental resection for malignant lung tumors.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of XLTF-UC180 Nodule Measurement with pathological morphology
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kazuhiro Yasufuku, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: