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

St. Joseph's Healthcare Hamilton

Status and phase: Enrolling; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT02570815

BFCRS-RP-001-1504-29

101

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

indocyanine green

Experimental group

Description:

Non-toxic, fluorescent dye

Treatment:

Drug: indocyanine green