Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound
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|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
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Device: Intraoperative ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218242
|United States, Kentucky|
|University of Kentucky, Markey Cancer Center|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Joel Thompson, PhD||University of Kentucky|