Recruiting
Phase 1
Phase 2

Synapse 3D with Indocyanine Green

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT03953144

Conditions

Non-small Cell Lung Cancer

Primary Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Synapse 3D Lung Modelling

IC-Green (ICG)

Study Details

Brief summary:

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.

Conditions

Non-small Cell Lung Cancer

Primary Neoplasm

Study ID

NCT03953144

Start date

Dec 1, 2022

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • Hypersensitivity or allergy to ICG, sodium iodide, or iodine
  • 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
  • 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.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Synapse 3D Lung Modelling + IC-GREEN Segmentectomy

Patients within this arm will undergo a high-resolution CT scan of the chest, which is required by Synapse 3D to create accurate 3D virtual model reconstructions. At the start of the operation, the 3D virtual model of the segmental pulmonary anatomy will be displayed on the da Vinci Robotic platform for operative planning. The model will be used as a guide to determine which vessels are involved in the segment and need to be removed. The surgeon will ligate the pulmonary vein and pulmonary artery of the broncho-pulmonary segment with the lung cancer nodule, isolating it from any blood supply, and mark the proposed segmental planes based on the 3D model. ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, an 8 mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10 mL saline solution bolus

Interventions

Synapse 3D Lung Modelling

The 3D virtual models provided by Synapse 3D will be made by experts in medical image analysis using the high-resolution CT scans. Patients will have 3D virtual reconstructions of their pulmonary anatomy with the target lesion created pre-operatively.

IC-Green (ICG)

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.

Primary outcome measure

  • Segmental Resection Conversion Rate [ Time Frame: 1 year ]
  • Number of Participants with Post Operative Complications [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Peter R. A. Malik, BHSc (Honours)

905-522-1155malikpr@mcmaster.ca

Yogita S Patel, BSc

905-522-1155patelys@mcmaster.ca

Locations

St. Josephs Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Yogita S Patel, BSc

905-522-1155patelys@mcmaster.ca

Principal Investigator:

Wael C. Hanna, MDCM, MBA, FRCSC

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

  • Segmentectomy
  • Lung Cancer
  • Robotic Surgery
  • 3D Modelling
  • CT Imaging
  • Near-Infrared Fluorescence
  • IC-GREEN
  • Surgical Planning
  • Indocyanine Green
  • Early-Stage Lung Cancer
  • Surgical Mapping
  • Lung Preservation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2026-02-02.