Synapse 3D With Intravascular Indocyanine Green

Recruiting now · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer, Primary Neoplasm

In brief

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.

Key facts

Study ID

NCT03953144

Run by

St. Joseph's Healthcare Hamilton

People needed

32

Starts

2022-12-01

Expected to finish

2026-12-31

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St. Josephs Healthcare Hamilton — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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