Synapse 3D With Intravascular Indocyanine Green
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Joseph's Healthcare Hamilton
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Synapse 3D Lung Modelling
DeviceThe 3D virtual models provided by Synapse 3D will be made by experts in medical image analysis using the high-resolution CT scans. Patients will have 3D virtual reconstructions of their pulmonary anatomy with the target lesion created pre-operatively.
IC-Green (ICG)
DrugICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, a 6 to 8mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10mL saline solution bolus. The Firefly camera will then be used for the NIF imaging. It is expected that the entire lung, except the segment which was previously isolated from blood supply, will fluoresce within 30-40 seconds, exhibiting a green hue. The surgeon will perform the pulmonary resection and the resected 'dark' lung segment will be immediately evaluated by a pathologist, depending on the pathologist findings the operation may be concluded or the patient will receive a pulmonary lobectomy.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Synapse 3D Lung Modelling + IC-GREEN SegmentectomyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Segmental Resection Conversion Rate
Rate of conversions to lobectomy will be measured by collecting the proportion of conversions to lobectomy.
Time frame
1 year2
Number of Participants with Post Operative Complications
Post operative complications will be reported and measured using the Ottawa Thoracic Morbidity and Mortality Classification of (a) Adverse reactions to ICG dye at the time of surgery and (b) Perioperative complications through study completion.
Time frame
1 yearSecondary outcomes
1
Anatomical Accuracy of the 3D Lung Model
Anatomical accuracy will be evaluated using the criteria listed in points a-c. A score of 3/3 on these items will indicate success of anatomical accuracy 1. Ex-vivo localization of lesions; 2. Ex-vivo confirmation of tumor-free margins around lesion; 3. Ex-vivo confirmation of adequate anatomical inter-segmental.
Time frame
1 year2
Surgeon Confidence
A pre-operative CT scan based, a pre-operative 3D reconstruction based and post segmental resection surgeon confidence score will be obtained on a scale of 1-5: 1 - not at all confident, 2 - somewhat confident, 3 - confident, 4 - very confident, 5 - extremely confident.
Time frame
1 year3
Operation Time
Length of time of the operation will be measured by collecting the time the patient entered the operating room until the time the patient left the operating room.
Time frame
1 year4
Conversion to Thoracotomy
Rate of conversion to thoracotomy will be measured by collecting the proportion of conversions to thoracotomy. Descriptive analysis of reasons for conversion will also be collected.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov