NCT03953144 Synapse 3D With Intravascular Indocyanine Green
| NCT ID | NCT03953144 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | St. Joseph's Healthcare Hamilton |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2022-12-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Waël C Hanna, MDCM, MBA, FRCSC
PRINCIPAL INVESTIGATOR
St. Joseph's Healthcare Hamilton / McMaster University
Frequently Asked Questions
Who can join the NCT03953144 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03953144 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03953144 currently recruiting?
Yes, NCT03953144 is actively recruiting participants. Contact the research team at malikpr@mcmaster.ca for enrollment information.
Where is the NCT03953144 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT03953144 clinical trial?
NCT03953144 is sponsored by St. Joseph's Healthcare Hamilton. The principal investigator is Waël C Hanna, MDCM, MBA, FRCSC at St. Joseph's Healthcare Hamilton / McMaster University. The trial plans to enroll 32 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.