Using 3D modeling and ICG for targeted lung cancer surgery
Official title: Synapse 3D With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial: A Phase I Safety and Feasibility Trial
Run by St. Joseph's Healthcare Hamilton · NCT03953144 · Data updated 2026-11-12
This study is testing whether using 3D models and a special dye can help doctors perform safer and more effective lung cancer surgeries for patients with small tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | St. Joseph's Healthcare Hamilton Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Status | Recruiting |
| Started | December 1, 2022 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 2, 2026 |
| Trial ID | NCT03953144 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with clinical stage 1 NSCLC and tumor sizes less than 3 cm that are confined to one broncho-pulmonary segment.
✕Probably not a fit
Patients with larger tumors, evidence of advanced disease, or significant pulmonary function impairment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to improve surgical outcomes for patients with early-stage non-small cell lung cancer (NSCLC) by utilizing preoperative 3D anatomical planning and intravascular indocyanine green (ICG) during robotic segmentectomy. The study will assess the effectiveness of this innovative approach in facilitating minimally invasive surgery, allowing for the removal of cancerous segments while preserving healthy lung tissue. By focusing on patients with small tumors confined to a single segment, the trial seeks to demonstrate the advantages of segmentectomy over traditional lobectomy, including reduced blood loss and shorter recovery times.
Why it matters
Potential benefit: If successful, this approach could significantly enhance surgical precision and patient outcomes for those with early-stage lung cancer.
How similar studies have gone: While the use of 3D modeling in surgical planning is gaining traction, this specific application in robotic segmentectomy for lung cancer is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
St. Josephs Healthcare Hamilton
Hamilton, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Waël C Hanna, MDCM, MBA, FRCSC — St. Joseph's Healthcare Hamilton / McMaster University
- Study coordinator: Peter R. A. Malik, BHSc (Honours)
- Email: malikpr@mcmaster.ca
- Phone: 905-522-1155
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.