ENB Robotic ICG Guided Surgery: A Novel Technique for Targeting Small Lung Tumors (ENB-RIGGS)
Primary Purpose
Non-small Cell Lung Cancer, Thoracic Surgery
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring robotic surgery, indocyanine green, electromagnetic navigational bronchoscopy
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Peripheral lung tumour that is <2 cm in size on a CT scan
- Fit to undergo thoracic surgery as assessed by the surgeon.
Exclusion Criteria:
- Hypersensitivity or allergy to ICG, sodium iodide or iodine
- Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Indocyanine green
Arm Description
Outcomes
Primary Outcome Measures
Safety determined by the rates of adverse reactions to ICG dye, intra-operative adverse events, and post-operative complications as defined by the Ottawa Thoracic Morbidity and Mortality classification
Reproducibility
Reproducibility will be measured by the aggregate score on items 1-4 of the 6-item scale which include: targeting of tumor on ENB (advance a bronchoscope to the targeted tumor); injection of the tumour with ICG; detection of ICG fluorescence with near-infrared light; wedge resection. The reproducibility score for each procedure will be the sum of the first 4 items on the 6-item scale and can range between 0/4 to 4/4. The reproducibility rate will be defined as the percentage of patients who score 4/4 on the reproducibility scale.
Oncological validity
The oncological validity score for each procedure will be the sum of the last 2 items on the 6-item scale (ex-vivo localization of tumor; ex-vivo confirmation of tumour-free margins) and can range between 0/2 to 2/2. The oncological validity rate will be defined as the percentage of patients who score 2/2 on the oncological validity scale.
Secondary Outcome Measures
Process Feasibility will be determined by recruitment rate (The proportion of patients enrolled in the study versus the number eligible, up to n=30)
Management Feasibility will be determined by the percentage of cases for which ICG was successfully obtained from pharmacy and prepared for the ENB-RIGGS procedure
Resource Feasibility will be determined by the sum of the dollar costs of the ENB-RIGGS materials and personnel required to perform the procedure, divided by the number of participants.
Full Information
NCT ID
NCT02570958
First Posted
October 6, 2015
Last Updated
June 1, 2017
Sponsor
St. Joseph's Healthcare Hamilton
1. Study Identification
Unique Protocol Identification Number
NCT02570958
Brief Title
ENB Robotic ICG Guided Surgery: A Novel Technique for Targeting Small Lung Tumors
Acronym
ENB-RIGGS
Official Title
Robotic ICG Guided Surgery (RIGGS) Using Electromagnetic Navigational Bronchoscopy (ENB): A Novel Technique for Targeting Small Lung Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Funding was not received
Study Start Date
October 2017 (Anticipated)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Lung cancer is the leading cause of cancer deaths worldwide. However, if diagnosed at an early stage (tumor <2 cm), lung cancer is highly curable with a 5-year survival rate greater than 80% after surgical resection. Screening tests have made it easier to identify small lung tumors. However, these tumors are often not visible to the naked eye, and surgeons cannot feel them, making them difficult to precisely locate and remove. For this reason, surgeons have become more reliant on image guided surgery for the removal of these tumors.
The standard of care for locating and removing small lung tumors is microcoil-guided video-assisted thoracoscopic surgery (VATS). This is a two-step procedure performed by two separate physicians.
First, patient is taken to radiology suite and radiologist inserts a microcoil near the lung tumor
Second (usually occurs a few hours later), patient is taken to operating room; a surgeon uses an x-ray arm to find the microcoil within the lung and remove it surgically.
A pathologist reviews the resected tissue to make sure that the tumor and the microcoil were both removed. Until this evaluation, the surgeon does not know whether the tumor has been removed or not. While this method is safe, it is time consuming, uses staff resources, and requires bulky equipment to complete.
In this study, we plan to develop and test a new method of identifying and removing small lung tumors. This procedure is called Electromagnetic Navigational Bronchoscopy (ENB) Robotic Indocyanine Green Guided Surgery (RIGGS) or ENB-RIGGS for a short name. The purpose of this study is to test the safety and reliability of the ENB-RIGGS surgery in the form of a pilot study.
ENB-RIGGS surgery is done in the operating room by a surgeon under general anesthetic. ENB-RIGGS begins by creating a 3-D GPS map of the lung which guides the surgeon directly to the tumor. A fluorescent green dye called indocyanine green is then injected into the tumor, and when viewed by the special robotic camera the tumour will fluoresce with a green hue allowing the surgeon to easily see the tumour. The surgeon then uses the robot to remove the tumor and surrounding tissue. The lung tissue specimen will be evaluated immediately by a pathologist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Thoracic Surgery
Keywords
robotic surgery, indocyanine green, electromagnetic navigational bronchoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indocyanine green
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Other Intervention Name(s)
IC-GREEN
Intervention Description
In the operating room ENB will be used to locate the targeted lung tumor. Once the tumor is located, the surgeon will advance a bronchoscope to the tumor, a needle will be passed through the bronchoscope, and the tumor will be injected with 100-150 micro liters of ICG solution at 0.125mg/mL concentration. The tumor is expected to fluoresce using the da Vinci Firefly robotic camera, giving off a bright green hue. Wedge resection of the fluorescent part of the lung will then be performed. The excised specimen will be sent for immediate pathologist analysis. If the tumor is found within the specimen, and the specimen margins are free of tumor cells, then the procedure will be completed. If the tumor cannot be targeted or visualized, or if the tumor is not found in the pathological specimen, or if the margins of the specimen contain tumor cells, then a formal anatomical lobectomy or segmental resection of the lung will be performed to ensure that the tumor is completely excised.
Primary Outcome Measure Information:
Title
Safety determined by the rates of adverse reactions to ICG dye, intra-operative adverse events, and post-operative complications as defined by the Ottawa Thoracic Morbidity and Mortality classification
Time Frame
Post-operatively, an average of 2 years
Title
Reproducibility
Description
Reproducibility will be measured by the aggregate score on items 1-4 of the 6-item scale which include: targeting of tumor on ENB (advance a bronchoscope to the targeted tumor); injection of the tumour with ICG; detection of ICG fluorescence with near-infrared light; wedge resection. The reproducibility score for each procedure will be the sum of the first 4 items on the 6-item scale and can range between 0/4 to 4/4. The reproducibility rate will be defined as the percentage of patients who score 4/4 on the reproducibility scale.
Time Frame
Post-operatively, an average of 2 years
Title
Oncological validity
Description
The oncological validity score for each procedure will be the sum of the last 2 items on the 6-item scale (ex-vivo localization of tumor; ex-vivo confirmation of tumour-free margins) and can range between 0/2 to 2/2. The oncological validity rate will be defined as the percentage of patients who score 2/2 on the oncological validity scale.
Time Frame
Post-operatively, an average of 2 years
Secondary Outcome Measure Information:
Title
Process Feasibility will be determined by recruitment rate (The proportion of patients enrolled in the study versus the number eligible, up to n=30)
Time Frame
pre-operatively, an average of 2 years
Title
Management Feasibility will be determined by the percentage of cases for which ICG was successfully obtained from pharmacy and prepared for the ENB-RIGGS procedure
Time Frame
pre-operatively, an average of 2 years
Title
Resource Feasibility will be determined by the sum of the dollar costs of the ENB-RIGGS materials and personnel required to perform the procedure, divided by the number of participants.
Time Frame
pre-operatively, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Peripheral lung tumour that is <2 cm in size on a CT scan
Fit to undergo thoracic surgery as assessed by the surgeon.
Exclusion Criteria:
Hypersensitivity or allergy to ICG, sodium iodide or iodine
Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waël C. Hanna, MDCM, MBA, FRCSC
Organizational Affiliation
St. Joseph's Healthcare Hamilton / McMaster University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21714641
Citation
National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
Results Reference
background
PubMed Identifier
25293355
Citation
Finley RJ, Mayo JR, Grant K, Clifton JC, English J, Leo J, Lam S. Preoperative computed tomography-guided microcoil localization of small peripheral pulmonary nodules: a prospective randomized controlled trial. J Thorac Cardiovasc Surg. 2015 Jan;149(1):26-31. doi: 10.1016/j.jtcvs.2014.08.055. Epub 2014 Sep 16.
Results Reference
background
PubMed Identifier
25527014
Citation
Hachey KJ, Colson YL. Current innovations in sentinel lymph node mapping for the staging and treatment of resectable lung cancer. Semin Thorac Cardiovasc Surg. 2014 Autumn;26(3):201-9. doi: 10.1053/j.semtcvs.2014.09.001. Epub 2014 Sep 16.
Results Reference
background
PubMed Identifier
25106680
Citation
Okusanya OT, Holt D, Heitjan D, Deshpande C, Venegas O, Jiang J, Judy R, DeJesus E, Madajewski B, Oh K, Wang M, Albelda SM, Nie S, Singhal S. Intraoperative near-infrared imaging can identify pulmonary nodules. Ann Thorac Surg. 2014 Oct;98(4):1223-30. doi: 10.1016/j.athoracsur.2014.05.026. Epub 2014 Aug 5.
Results Reference
background
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ENB Robotic ICG Guided Surgery: A Novel Technique for Targeting Small Lung Tumors
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