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Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Video-Assisted Thoracic Surgery (VATS) wedge resection
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 lung nodule, lung cancer, lung mass

Eligibility Criteria

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

Inclusion Criteria:

  • peripheral lung nodules < 3cm in size
  • Surgical candidate

Exclusion Criteria:

  • Non surgical candidate

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CT Marking and VATS lung wedge resection

Arm Description

Each patient with a lung nodule meeting criteria will undergo marking with fiducials followed at the same time by Video-Assisted Thoracic Surgery (VATS) lung wedge resection under CT fluoroscopy.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
The patient will be monitored while in the hospital by their thoracic surgical team as well as by two research nurses named Lauren Donahue, RN and Karen Magsipoc, NP. The research nurses will document any perioperative complications and mortality that arise during the patient's stay in the hospital.

Secondary Outcome Measures

Patients Underwent a Successful Resection
Number of patients who underwent a successful resection which is measured by an accurate and appropriate resection in a given timeline

Full Information

First Posted
May 2, 2013
Last Updated
January 29, 2019
Sponsor
Brigham and Women's Hospital
Collaborators
Siemens Medical Solutions USA - CSG
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1. Study Identification

Unique Protocol Identification Number
NCT01847209
Brief Title
Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions
Official Title
Percutaneous Image Guided Video Assisted Thoracic Surgery (VATS) Resection of Lung Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Siemens Medical Solutions USA - CSG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase II protocol to determine the safety and feasibility of Intraoperative CT fluoroscopy guidance for lung resection for small nodules.
Detailed Description
This is a phase II protocol to determine the safety and feasibility of image guided CT marking for resection of small lung nodules. This is relevant because many such nodules are hard to localize for minimally invasive lung resection. It is hoped that this technology using fluoro CT capability available now in most operating room will improve safety and reliability of thoracic surgery.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT Marking and VATS lung wedge resection
Arm Type
Experimental
Arm Description
Each patient with a lung nodule meeting criteria will undergo marking with fiducials followed at the same time by Video-Assisted Thoracic Surgery (VATS) lung wedge resection under CT fluoroscopy.
Intervention Type
Procedure
Intervention Name(s)
Video-Assisted Thoracic Surgery (VATS) wedge resection
Other Intervention Name(s)
Nodules marked with fiducials such as Kopan needles under CT fluoroscopy followed by VATS wedge resection.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Description
The patient will be monitored while in the hospital by their thoracic surgical team as well as by two research nurses named Lauren Donahue, RN and Karen Magsipoc, NP. The research nurses will document any perioperative complications and mortality that arise during the patient's stay in the hospital.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Patients Underwent a Successful Resection
Description
Number of patients who underwent a successful resection which is measured by an accurate and appropriate resection in a given timeline
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: peripheral lung nodules < 3cm in size Surgical candidate Exclusion Criteria: Non surgical candidate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael Bueno, M.D.
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

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
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Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions

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