3D lung planning and green dye to guide surgery for early lung cancer
Tests 3D planning and green dye in lung surgery for lung cancer.
Plain-language title generated from the registry record
Registry title: Synapse 3D With Intravascular Indocyanine Green
Key facts
- Where
- Hamilton, CanadaSee the site
- Phase
- Phase 1/2
Where in Canada
- St. Josephs Healthcare HamiltonHamilton, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- St. Joseph's Healthcare Hamilton
- Trial code
- NCT03953144
- Record updated
- 2 February 2026
- Original description
With the advent of CT screening for lung cancer, an increasing number of NSCLCs are being detected at very early stages, and the demand for pulmonary segmentectomy is rising rapidly. As such, there is a need to develop new surgical techniques to facilitate minimally invasive pulmonary segmentectomy, as segmentectomy may provide a number of significant advantages over lobectomy for patients presenting with early-stage lung cancer, or for patients unable to undergo a full lobectomy due to existing comorbidities. This study will provide the first case series using preoperative 3D anatomical planning (Synapse 3D) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Synapse 3D-guided targeted pulmonary segmental resection in Canada. As lung cancer is the most frequently fatal cancer in North America, many thousands of patients will be able to benefit from this operation every year.Read full original descriptionShow less
Synapse 3D With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial: A Phase I Safety and Feasibility Trial
With the advent of CT screening for lung cancer, an increasing number of NSCLCs are being detected at very early stages, and the demand for pulmonary segmentectomy is rising rapidly. As such, there is a need to develop new surgical techniques to facilitate minimally invasive pulmonary segmentectomy, as segmentectomy may provide a number of significant advantages over lobectomy for patients presenting with early-stage lung cancer, or for patients unable to undergo a full lobectomy due to existing comorbidities. This study will provide the first case series using preoperative 3D anatomical planning (Synapse 3D) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Synapse 3D-guided targeted pulmonary segmental resection in Canada. As lung cancer is the most frequently fatal cancer in North America, many thousands of patients will be able to benefit from this operation every year.
Inclusion: Tumour size <3 cm; Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC); CT-imaging confirming that the tumour is confined to one broncho-pulmonary segment, rendering the patient a candidate for segmental resection.
Exclusion: Women who are currently pregnant or breastfeeding; or women of childbearing potential who are not currently taking adequate birth control; Patients with clinical evidence of N1 or N2 disease on preoperative imaging; Hypersensitivity or allergy to ICG, sodium iodide, or iodine; Pulmonary Function tests demonstrating Forced Expiratory Volume in 1s (FEV1) or diffusion capacity of the lung for carbon monoxide (DLCO) less than or equal to 30% of predicted.