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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Yolonda Colson, MD, PhD
ycolson@partners.org
617-726-5200
Backup
Isha Mehta Warikoo, MD
imehtawarikoo@mgh.harvard.edu
18572501355
Time Frame
Start Date: 2015-01-06
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 100
Treatments
Experimental: ICG Intervention
The intervention to be administered is the indocyanine green for NIR Lymphatic Mapping. All study subjects will receive this same intervention; there is only one arm.
Related Therapeutic Areas
Sponsors
Collaborators: Brigham and Women's Hospital, Society of University Surgeons
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov