Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound

• ClinicalTrials.gov Identifier: NCT02218242
• Recruitment Status: Terminated
• First Posted: August 18, 2014
• Results First Posted: November 7, 2018
• Last Update Posted: November 7, 2018
• Sponsor: Joel Thompson, PhD
• Information provided by (Responsible Party): Joel Thompson, PhD, University of Kentucky

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Device: Intraoperative ultrasound	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single-arm, Phase II Study of Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound at the Time of Definitive Resection
• Actual Study Start Date: July 1, 2015
• Actual Primary Completion Date: June 27, 2018
• Actual Study Completion Date: June 27, 2018

Arms and Interventions

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 Name: B-K Medical/Analogic 8666-Radio Frequency laparoscopic ultrasound transducer and the bedside flex Focus 1202 imaging system

Outcome Measures

Primary Outcome Measures :

1. Detection of Occult Pathologic N2 Lymph Nodes [ Time Frame: At time of surgery ]
   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.

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

United States, Kentucky

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, United States, 40536

Sponsors and Collaborators

Joel Thompson, PhD

Investigators

• Principal Investigator: Joel Thompson, PhD; University of Kentucky

  Study Documents (Full-Text)

Documents provided by Joel Thompson, PhD, University of Kentucky:

Study Protocol and Statistical Analysis Plan  [PDF] November 7, 2013

More Information

• Responsible Party: Joel Thompson, PhD, Compliance Administrator, University of Kentucky
• ClinicalTrials.gov Identifier: NCT02218242
• Other Study ID Numbers: 13-LUN-95-MCC
• First Posted: August 18, 2014
• Results First Posted: November 7, 2018
• Last Update Posted: November 7, 2018
• Last Verified: October 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Joel Thompson, PhD, University of Kentucky:

Lung; Cancer; Ultrasound; Staging

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases