Lung Cancer
Conditions
Keywords
image guided, lung nodule, lung cancer, lung mass
Brief summary
To evaluate workflow and outcomes of iVATS and standard VATS for small pulmonary nodules. The outcomes of the patients will be evaluated separately as there will be no direct comparison of the two arms.
Detailed description
This is a prospective phase II clinical study to evaluate iVATS and standard VATS for small pulmonary nodules. We have successfully completed and published a phase I/pilot study with 25 patients demonstrating safety and optimal procedural workflow for combining image-guidance with VATS. This phase II clinical study will further expand upon the safety and feasibility of this procedure. Additionally, this data will be used to design a phase III comparison study between iVATS and standard VATS.
Interventions
DEVICEImage guided Video-Assisted Thoracic Surgery (VATS) resection
Image guided placement of a fiducial consisting of a needle directed placement of a T-Bar next to the target lesion in order to lead the surgeon to the lung region to be removed
PROCEDUREVideo-Assisted Thoracic Surgery
Standard of Care Video-Assisted Thoracic Surgery (VATS) resection
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be 18 years and older * Subject must be deemed a candidate for the iVATS surgery, by their treating Thoracic Surgeon * Subject must have nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension with longest diameter ≤ 20 mm or 2cm * Subject's lesions that are located in the outer half portion of the lung/lobe. * Subjects must be evaluated at BWH and/or DFCI Thoracic Surgery outpatient clinics
Exclusion criteria
* If participant is a pregnant woman or breast feeding they will not be eligible. * If treating thoracic surgeon deems the participant not eligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operating Room Time | 3 years to complete | The time (in min.) from incision to close |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to T-bar placement | 3 years | The time from patient ready for surgery to placement of t-bar |
| Time for induction to incision | 3 years | Time (in min) from induction to incision made |
| Hospital Length of Stay | 3 years | Length of hospital stay (in days) in both arms |
| Radiation Exposure | 3 years | The radiation exposure (mSV) in the iVATS arm |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Analysis of CT scans | 3 years | To collect imaging data from pre-operative and post-operative CT scans for quantitative analysis from both arm. |
Countries
United States
Contacts
Primary ContactJulianne S Barlow
Outcome results
None listed