Using 3D modeling and ICG for targeted lung cancer surgery
Synapse 3D With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial: A Phase I Safety and Feasibility Trial
PHASE1; PHASE2 · St. Joseph's Healthcare Hamilton · NCT03953144
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 |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Joseph's Healthcare Hamilton (other) |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT03953144 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with larger tumors, evidence of advanced disease, or significant pulmonary function impairment may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hamilton, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-small Cell Lung Cancer, Primary Neoplasm, Segmentectomy, Lung Cancer, Robotic Surgery, 3D Modelling, CT Imaging, Near-Infrared Fluorescence