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Image Guided VATS vs. VATS Resection

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Image guided Video-Assisted Thoracic Surgery (VATS) resection
Video-Assisted Thoracic Surgery
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring image guided, lung nodule, lung cancer, lung mass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iVATS resection

Standard VATS resection

Arm Description

Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.

Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.

Outcomes

Primary Outcome Measures

Operating Room Time
The time (in min.) from incision to close

Secondary Outcome Measures

Time to T-bar placement
The time from patient ready for surgery to placement of t-bar
Time for induction to incision
Time (in min) from induction to incision made
Hospital Length of Stay
Length of hospital stay (in days) in both arms
Radiation Exposure
The radiation exposure (mSV) in the iVATS arm

Full Information

First Posted
July 20, 2018
Last Updated
February 6, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03623958
Brief Title
Image Guided VATS vs. VATS Resection
Official Title
Image Guided VATS Resection vs. VATS Resection of Lung Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
image guided, lung nodule, lung cancer, lung mass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iVATS resection
Arm Type
Experimental
Arm Description
Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.
Arm Title
Standard VATS resection
Arm Type
Active Comparator
Arm Description
Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.
Intervention Type
Device
Intervention Name(s)
Image guided Video-Assisted Thoracic Surgery (VATS) resection
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Video-Assisted Thoracic Surgery
Intervention Description
Standard of Care Video-Assisted Thoracic Surgery (VATS) resection
Primary Outcome Measure Information:
Title
Operating Room Time
Description
The time (in min.) from incision to close
Time Frame
3 years to complete
Secondary Outcome Measure Information:
Title
Time to T-bar placement
Description
The time from patient ready for surgery to placement of t-bar
Time Frame
3 years
Title
Time for induction to incision
Description
Time (in min) from induction to incision made
Time Frame
3 years
Title
Hospital Length of Stay
Description
Length of hospital stay (in days) in both arms
Time Frame
3 years
Title
Radiation Exposure
Description
The radiation exposure (mSV) in the iVATS arm
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Quantitative Analysis of CT scans
Description
To collect imaging data from pre-operative and post-operative CT scans for quantitative analysis from both arm.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julianne S Barlow
Phone
617-525-8704
Email
jbarlow1@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael Bueno, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphael Bueno, MD
Phone
617-732-5004
Email
rbueno@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Julianne Barlow
Phone
617-525-8704
Email
jbarlow1@bwh.harvard.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
26031893
Citation
Gill RR, Zheng Y, Barlow JS, Jayender J, Girard EE, Hartigan PM, Chirieac LR, Belle-King CJ, Murray K, Sears C, Wee JO, Jaklitsch MT, Colson YL, Bueno R. Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial. J Surg Oncol. 2015 Jul;112(1):18-25. doi: 10.1002/jso.23941. Epub 2015 May 28.
Results Reference
result

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Image Guided VATS vs. VATS Resection

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