NCT03097575

Bronchial NIR Image-guided Resection

Bronchial NIR Image-guided Resection, Mapping And Targeted Lymphadenectomy for Lung Lesions

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical trial to evaluate the use of peritumoral injection of near-infrared dye indocyanine green to identify lung lesions and sentinel lymph nodes. The primary purpose is to determine if the use of ICG injected via navigational bronchoscopy, CT-guided or transthoracic allows us to identify the first lymph node that drains from the tumor, and thus would be the most likely site for metastatic disease, and remove it for analysis to improve the ability to detect tumor in this node and to remove this additional site that potentially contains tumor cells. Using this intraoperative imaging technique, we aim to improve the identification of lung nodules for resection and the intraoperative identification of sentinel lymph nodes in the event that a lymphadenectomy is performed.

Detailed description

Patients enrolled in the study will undergo peritumoral injection of near-infrared dye indocyanine green around the lung lesion or within the adjacent segmental bronchus at the time of surgery. ICG injection will be carried out via navigational bronchoscopy, CT-guided or trans-thoracic ICG injection (dependent on lesion location) and ICG imaging of the sentinel lymph nodes will be undertaken using an NIR-enabled camera. * This study is designed primarily to determine the safety and feasibility of intra-operative localization of thoracic lesions following ICG injection, and second, to include an assessment of the predictive value of sentinel lymph nodes relative to the disease status of the greater lymphadenectomy specimen as well as disease recurrence rates. * We are using a dose approximately 100 times lower than previously approved for injection in the blood. After a few minutes, the surgeon will look at these lymph nodes with near-infrared fluorescence and then remove any fluorescent and non-fluorescent lymph nodes near the tumor, as is standard for lung surgery. * The "filtered" near-infrared light causes the indocyanine green dye to fluoresce so that the surgeon can identify the lymph nodes most likely to contain tumor cells. If the lymph node is not found in the group of nodes usually removed, we will use the near-infrared light to look near the tumor for the sentinel lymph nodes and guide the surgeon so that the sentinel nodes can be removed and studied. The surgeon will then continue with the operation and remove the tumor. The lymph nodes are processed for special analysis tailored to finding metastasis in sentinel lymph nodes. * As is standard of care, patients will be monitored for evidence of recurrence by their surgeon. Recurrences will be recorded.

Conditions

• Sentinel Lymph Node

Interventions

Type	Name	Description
DRUG	ICG Intervention	Patients enrolled in the study will undergo injection of near infrared dye indocyanine green around the lung lesion or within the adjacent segmental bronchus at the time of surgery via navigational bronchoscopy, or if not amenable to navigational bronchoscopy injection, then injection will be carried out via a transthoracic approach through the incision or under CT-guidance.
DEVICE	Near Infrared Imaging	A near-infrared camera device will be used to detect indocyanine green following injection.

Timeline

• Start date: 2015-01-06
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2017-03-31
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study