Bronchial NIR Image-guided Resection

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital; Massachusetts General Hospital
• Collaborators: Brigham and Women's Hospital; Society of University Surgeons

Criteria

Inclusion Criteria:

• Patients that have agreed to undergo video assisted thoracoscopic surgery or thoracotomy for surgical resection as recommended by their thoracic surgeon.

• 18 years of age or older

• Documented, signed, dated informed consent obtained prior to any study specific procedures being performed

Exclusion Criteria:

• Pregnant women are excluded and women of childbearing potential without a negative pregnancy test prior to study procedures. All patients with Iodine allergies will be excluded.