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Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218242
Recruitment Status : Terminated (Unable to enroll enough participants)
First Posted : August 18, 2014
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Joel Thompson, PhD, University of Kentucky

Tracking Information
First Submitted Date  ICMJE August 13, 2014
First Posted Date  ICMJE August 18, 2014
Results First Submitted Date  ICMJE June 28, 2018
Results First Posted Date  ICMJE November 7, 2018
Last Update Posted Date November 7, 2018
Actual Study Start Date  ICMJE July 1, 2015
Actual Primary Completion Date June 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2014)
Rate of detection of occult pathologic N2 lymph nodes [ Time Frame: At time of surgery ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound
Official Title  ICMJE A Single-arm, Phase II Study of Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound at the Time of Definitive Resection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Device: Intraoperative ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 9, 2018)
9
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2014)
70
Actual Study Completion Date  ICMJE June 27, 2018
Actual Primary Completion Date June 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02218242
Other Study ID Numbers  ICMJE 13-LUN-95-MCC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joel Thompson, PhD, University of Kentucky
Study Sponsor  ICMJE Joel Thompson, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joel Thompson, PhD University of Kentucky
PRS Account University of Kentucky
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP