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Synapse 3D + IC-Green for Early-Stage Lung Cancer

Phase 1 & 2
Recruiting
Led By Waël C Hanna, MDCM, MBA, FRCSC
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will study a new surgical technique to facilitate minimally invasive pulmonary segmentectomy, which may provide advantages over lobectomy for patients with early-stage lung cancer or comorbidities.

Who is the study for?
This trial is for individuals with early-stage Non-Small Cell Lung Cancer (NSCLC), specifically those with tumors smaller than 3 cm and confined to one lung segment. It's not suitable for patients allergic to ICG or iodine, pregnant or breastfeeding women, or those without effective birth control. People with certain lung function test results indicating severe impairment are also excluded.Check my eligibility
What is being tested?
The study tests a new surgical technique using Synapse 3D preoperative planning combined with IC-Green (ICG) during minimally invasive robotic surgery for lung cancer. The goal is to improve outcomes in pulmonary segmentectomy, which could benefit many patients annually.See study design
What are the potential side effects?
Potential side effects may include reactions related to the use of IC-Green such as allergy symptoms due to sensitivity towards the dye used in imaging. Surgical risks can also be expected from the procedure itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is early-stage non-small cell lung cancer.
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My CT scan shows my lung tumor is small enough for a specific type of surgery.
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My tumor is smaller than 3 cm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Post Operative Complications
Segmental Resection Conversion Rate
Secondary outcome measures
Anatomical Accuracy of the 3D Lung Model
Chest Tube Duration
Conversion to Thoracotomy
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Synapse 3D Lung Modelling + IC-GREEN SegmentectomyExperimental Treatment2 Interventions
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

Find a Location

Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor
195 Previous Clinical Trials
25,392 Total Patients Enrolled
Waël C Hanna, MDCM, MBA, FRCSCPrincipal InvestigatorSt. Joseph's Healthcare Hamilton / McMaster University
3 Previous Clinical Trials
710 Total Patients Enrolled

Media Library

Synapse 3D Lung Modelling + IC-GREEN Segmentectomy Clinical Trial Eligibility Overview. Trial Name: NCT03953144 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Synapse 3D Lung Modelling + IC-GREEN Segmentectomy
Non-Small Cell Lung Cancer Clinical Trial 2023: Synapse 3D Lung Modelling + IC-GREEN Segmentectomy Highlights & Side Effects. Trial Name: NCT03953144 — Phase 1 & 2
Synapse 3D Lung Modelling + IC-GREEN Segmentectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03953144 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots remaining for participants in this research trial?

"Unfortunatley this trial has concluded its recruitment process. It began on January 1st 2023 and was last updated November 2nd 2022, so it is no longer open to enrollment. Fortunately there are still 1576 trials actively recruiting patients with non-small cell lung cancer and 30 studies that require VisiblePatient™ 3D Lung Modelling participants."

Answered by AI

What are the primary objectives of this research endeavor?

"This medical trial seeks to measure the Segmental Resection Conversion Rate over a one year period as its primary outcome. Secondary outcomes being considered include Length of Stay, Anatomical Accuracy of the 3D Lung Model, and Surgeon Confidence. The latter is rated on a scale from 1-5: 'not at all confident' to 'extremely confident'."

Answered by AI

How many participants are currently involved in this medical research?

"At present, this study is not enrolling candidates. The research project was initially posted on January 1st 2023 and its last update occurred on November 2nd 2022. If you are investigating other studies, there are currently 30 trials for VisiblePatient™ 3D Lung Modelling recruiting participants as well as 1576 medical experiments involving those with non-small cell lung cancer in search of volunteers."

Answered by AI
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~9 spots leftby Sep 2024