Clinical trial NCT02570958: ENB Robotic ICG Guided Surgery: A Novel Technique for Targeting Small Lung Tumors
Official title: Robotic ICG Guided Surgery (RIGGS) Using Electromagnetic Navigational Bronchoscopy (ENB): A Novel Technique for Targeting Small Lung Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Thoracic Surgery
Keywords: robotic surgery
indocyanine green
electromagnetic navigational bronchoscopy
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. Peripheral lung tumour that is \<2 cm in size on a CT scan
3. Fit to undergo thoracic surgery as assessed by the surgeon.

Exclusion Criteria:

1. Hypersensitivity or allergy to ICG, sodium iodide or iodine
2. Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control.

Primary outcomes:
measure: 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
timeFrame: Post-operatively, an average of 2 years
measure: Reproducibility
timeFrame: Post-operatively, an average of 2 years
measure: Oncological validity
timeFrame: Post-operatively, an average of 2 years
Secondary outcomes:
measure: Process Feasibility will be determined by recruitment rate (The proportion of patients enrolled in the study versus the number eligible, up to n=30)
timeFrame: pre-operatively, an average of 2 years
measure: 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
timeFrame: pre-operatively, an average of 2 years
measure: 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.
timeFrame: pre-operatively, an average of 2 years
Other outcomes:
Locations:
Study officials:
affiliation: St. Joseph's Healthcare Hamilton / McMaster University
name: Waël C. Hanna, MDCM, MBA, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.