Synapse 3D With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial: A Phase I Safety and Feasibility Trial

Who is this study for? Patients with non-small cell lung cancer who are candidates for segmental resection
What treatments are being studied? Synapse 3D Lung Modelling+IC-Green
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
St. Josephs Healthcare Hamilton
RECRUITING
Hamilton
Contact Information
Primary
Peter R. A. Malik, BHSc (Honours)
malikpr@mcmaster.ca
905-522-1155
Backup
Yogita S Patel, BSc
patelys@mcmaster.ca
905-522-1155
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 32
Treatments
Experimental: Synapse 3D Lung Modelling + IC-GREEN Segmentectomy
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
Sponsors
Leads: St. Joseph's Healthcare Hamilton

This content was sourced from clinicaltrials.gov