Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound

NCT02218242 | Terminated Results DMC FDA Device

• 1 other identifier: 13-LUN-95-MCC
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung; Cancer; Ultrasound; Staging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Ultrasound

EXPERIMENTAL

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

Interventions

Intraoperative ultrasound DEVICE

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.

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

Ultrasound

Eligibility Criteria

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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Joel Thompson, PhD: lead

Study Sites (1)

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The University of Kentucky Medical Center did not treat a sufficient patient population to enroll and complete this study.

Results Point of Contact

• Title: Angela Mahan
• Organization: University of Kentucky

angela.mahan@uky.edu

859 257 4488

Study Officials

• Joel Thompson, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Compliance Administrator

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 18, 2014
• Study Start: July 1, 2015
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: November 7, 2018
• Results First Posted: November 7, 2018

Record last verified: 2018-10

Locations

US (1)