Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound

Study summary

All patients undergoing video-assisted thoracoscopic (VATS) resection of lung cancer will receive standard therapy including lobectomy or sub-lobar resection and mediastinal lymph node dissection. After completion of the standard of care, intraoperative ultrasound will be used to evaluate lymph node stations for the presence of any missed lymph nodes with particular focus on lymph nodes which may appear pathologic on ultrasound evaluation. Data will be reviewed for rates of pathologic upstaging, and sensitivity and specificity of ultrasound as an additional diagnostic tool in the operating room will be evaluated. It is hypothesized that Intra-operative thoracoscopic ultrasound following standard video-assisted thoracoscopic (VATS) dissection will increase the rate of pathologically staged in N2 nodes in non-small cell lung cancer patients undergoing definitive surgical resection.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIntraoperative ultrasound

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 7, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Joel Thompson, PhD

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Not applicable
Sponsor: Joel Thompson, PhD
Interventions being studied: Device: Intraoperative ultrasound

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Surgery→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Age ≥18 years. Eastern Cooperative Oncology Group performance status ≤2 (Karnofsky ≥60%, see Appendix A). Life expectancy of greater than 3 months Patients be able to undergo VATS resection as defined below:
Preoperative Forced Expiratory Volume at one second ≥ 40% predicted
OR
Post-operative predicted Forced Expiratory Volume at one second ≥ 0.8 l
Hg ≥ 8.0
No evidence of coronary ischemia on stress evaluation Ability to understand and the willingness to sign a written informed consent document.

Reasons someone may not be able to joinExclusion criteria

Patients with surgery for a prior ipsilateral lung cancer Patients with known brain metastases Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. (Patients with HIV are not excluded from this study)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Kentucky, Markey Cancer CenterLexington, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 7, 2018. Always confirm current availability with the study team.

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