Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer

NCT02570815 | Recruiting Phase 1

• 2 other identifiers: BFCRS-RP-001-1504-29101
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Lungs are made up of individual lobes. When a lung cancer tumour is detected in one of these lobes, surgeons typically perform a Lobectomy. A Lobectomy is the surgery most commonly done to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which removes a large amount of lung tissue For patients with small tumours saving as much healthy lung tissue as possible is important. Each lobe of the lung has smaller sections called segments. When a lung cancer is in one of these segments, it is possible to remove that segment, without removing the entire lobe. This surgery is called a segmentectomy. Compared to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue. With the advances in screening technology for lung cancer tumours, an increasing amount of very small lung cancer tumours are being found, and the demand for segmentectomy is increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult to view the tissue lines that separate each segment within the lobe. As a result, it is difficult for the surgeon to see exactly which pieces of tissue should be removed. Because of these challenges, many patients having robotic surgery will have a lobectomy, even if a full lobectomy is not needed. Near-Infrared Fluorescence (NIF) using indocyanine green (ICG) fluorescent dye is a recent advancement in the robotic platform of robotic surgery. The surgeon will view the CT scan to determine which segment the tumour is located in. Once identified, the surgeon will isolate the segment by cutting off the blood supply to that segment. Then ICG will be injected into a vein. It is expected that the entire lung, except the isolated segment, which will remain 'dark' as it was isolated from blood supply, will fluoresce, giving off a green hue when viewed with the da Vinci Firefly camera. The surgeon will identify 'dark' segment, and will remove it. A pathologist will examine the excised tissue to ensure that the tumour was removed in its entirety. Once confirmed, the surgeon will end the procedure. If the pathologist determines that the segment removed did not contain the entire tumour, then the surgeon will perform a routine lobectomy. This ensures patient safety and confirms that all participants will have the entire tumour removed from their lung.

Conditions

Non-small Cell Lung Cancer

Keywords

lung cancer; segmentectomy; robotic surgery; near-infrared fluorescent; IC-GREEN; indocyanine green; early-stage lung cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of using NIF-guidance in robotic pulmonary segmentectomy for early-stage lung cancer will be evaluated using items 1, 2, and 3 of a 7-item binary rating scale. An score of 3/7 for these items will indicate success.

  Item 1: Visualization of fluoresced lung by NIF imaging; Item 2:Demarcation of a dark segment and inter-segmental plane; Item 3: Completion of segmental resection along the borders of the dark-segmental plane.

  1 year

Secondary Outcomes (14)

• Safety will be measured by the rate of adverse reactions to ICG dye as defined by the Ottawa Thoracic Morbidity and Mortality classification

  1 year

• Safety will also be measured by the rate of perioperative complications as defined by the Ottawa Thoracic Morbidity and Mortality classification

  1 year

• Anatomical accuracy will be evaluated using items 4, 5, and 6 of the Indocyanine Green Segmentectomy 7-Item Binary Scale. A score of 3/7 on these items will indicate success of anatomical accuracy

  1 year

• Added value of ICG-guidance will be evaluated using Item 7 of the 7-item binary rating scale. A score of 1/7 will indicate added value of ICG-guidance

  1 year

• Overall success of the intervention will be evaluated using Items 1-7 of the binary rating scale, only an aggregate score of 7/7 will be considered a success

  1 year

Study Arms (1)

indocyanine green

EXPERIMENTAL

Non-toxic, fluorescent dye

Drug: indocyanine green

Interventions

indocyanine green DRUG

ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, a 6 to 8mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10mL saline solution bolus. The Firefly camera will then be used for the NIF imaging. It is expected that the entire lung, except the segment which was previously isolated from blood supply, will fluoresce within 30-40 seconds, exhibiting a green hue. The surgeon will perform the pulmonary resection and the resected 'dark' lung segment will be immediately evaluated by a pathologist, depending on the pathologist findings the operation may be concluded or the patient will receive a pulmonary lobectomy.

Also known as: IC-GREEN

indocyanine green

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Tumor size \<3 cm
• Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC)
• CT-imaging confirming that the tumour is confined to the one broncho-pulmonary segment, rendering the patient a candidate for segmental resection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Related Publications (5)

• Landreneau RJ, Sugarbaker DJ, Mack MJ, Hazelrigg SR, Luketich JD, Fetterman L, Liptay MJ, Bartley S, Boley TM, Keenan RJ, Ferson PF, Weyant RJ, Naunheim KS. Wedge resection versus lobectomy for stage I (T1 N0 M0) non-small-cell lung cancer. J Thorac Cardiovasc Surg. 1997 Apr;113(4):691-8; discussion 698-700. doi: 10.1016/S0022-5223(97)70226-5.

  PMID: 9104978 BACKGROUND

• Zhao X, Qian L, Luo Q, Huang J. Segmentectomy as a safe and equally effective surgical option under complete video-assisted thoracic surgery for patients of stage I non-small cell lung cancer. J Cardiothorac Surg. 2013 Apr 29;8:116. doi: 10.1186/1749-8090-8-116.

  PMID: 23628209 BACKGROUND

• Pardolesi A, Veronesi G, Solli P, Spaggiari L. Use of indocyanine green to facilitate intersegmental plane identification during robotic anatomic segmentectomy. J Thorac Cardiovasc Surg. 2014 Aug;148(2):737-8. doi: 10.1016/j.jtcvs.2014.03.001. Epub 2014 Mar 5. No abstract available.

  PMID: 24680390 BACKGROUND

• 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.

  PMID: 25293355 BACKGROUND

• Ivanovic J, Al-Hussaini A, Al-Shehab D, Threader J, Villeneuve PJ, Ramsay T, Maziak DE, Gilbert S, Shamji FM, Sundaresan RS, Seely AJ. Evaluating the reliability and reproducibility of the Ottawa Thoracic Morbidity and Mortality classification system. Ann Thorac Surg. 2011 Feb;91(2):387-93. doi: 10.1016/j.athoracsur.2010.10.035.

  PMID: 21256276 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Waël C. Hanna, MDCM, MBA, FRCSC

  St. Joseph's Healthcare Hamilton / McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa L Patterson, BA

CONTACT

905-522-1155; patterls@stjoes.ca

Christine Fahim, PhD(c)

CONTACT

905-522-1155; tfahim@stjosham.on.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Research Program, Boris Family Centre for Robotic Surgery

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 7, 2015
• Study Start: October 1, 2016
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)