Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound

A Single-arm, Phase II Study of Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound at the Time of Definitive Resection

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Intraoperative ultrasound

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky, Markey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion 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.

Exclusion 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ultrasound; Participants in this study have elected to have surgical resection of non-small cell lung cancer tumors as part of their standard of care. During that surgical procedure, participants will also receive laparoscopic intraoperative ultrasound to assess the thoracic wall lymph nodes as part of the experimental procedure. The ultrasound procedure will add about 15 minutes to the total surgical time. Because it is laparoscopic and utilizes non-ionizing radiation, the risk to the participant is minimal.

Device: Intraoperative ultrasound; Intraoperative ultrasound will be performed at the completion of the standard lung cancer resection with mediastinal lymph node dissection. This evaluation will be performed by a different surgeon from the primary surgeon performing the operation to minimize operator variability with the ultrasound system and help control for bias. Additional lymph nodes identified will be resected and sent for pathologic evaluation. It is anticipated that this additional evaluation and treatment should take no more than 30 minutes and as such a time limit of 30 minutes from introduction of the ultrasound probe into the surgical field will be set.; Other Names: B-K Medical/Analogic 8666-Radio Frequency laparoscopic ultrasound transducer and the bedside flex Focus 1202 imaging system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of Occult Pathologic N2 Lymph Nodes	Participants undergoing resection of lung tumors will have laparoscopic thoracic wall ultrasound in an attempt to identify pathologic N2 lymph nodes. Data will be presented as the ratio of lymph nodes identified as cancerous to the total number of lymph nodes investigated with the ultrasound technique.	At time of surgery

Collaborators and Investigators

• Sponsor: Joel Thompson, PhD
• Investigators: Principal Investigator: Joel Thompson, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): June 27, 2018
• Study Completion (Actual): June 27, 2018

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 18, 2014

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Ultrasound; Cancer; Lung; Staging
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 13-LUN-95-MCC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes