Back to resultsThoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound
Primary Purpose
Lung Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraoperative ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Lung, Cancer, Ultrasound, Staging
Eligibility 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)
Sites / Locations
- University of Kentucky, Markey Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02218242
Brief Title
Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll enough participants
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
June 27, 2018 (Actual)
Study Completion Date
June 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joel Thompson, PhD
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung, Cancer, Ultrasound, Staging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intraoperative ultrasound
Other Intervention Name(s)
B-K Medical/Analogic 8666-Radio Frequency laparoscopic ultrasound transducer and the bedside flex Focus 1202 imaging system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Detection of Occult Pathologic N2 Lymph Nodes
Description
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.
Time Frame
At time of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Thompson, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky, Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound
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