Actively Recruiting
Bronchial Near-Infrared Image-Guided Resection, Mapping and Targeted Lymphadenectomy for Lung Lesions
Led by Massachusetts General Hospital · Updated on 2025-11-10
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
S
Society of University Surgeons
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a near-infrared dye called indocyanine green (ICG) to help identify lung lesions and the sentinel lymph nodes, which are the first lymph nodes that drain from a tumor. This trial aims to see if injecting ICG near the tumor during surgery can improve the detection and removal of lymph nodes that may contain cancer cells, potentially improving lung cancer surgery outcomes. The study also assesses the safety and feasibility of this imaging method during surgery. Participants will receive an injection of ICG dye around the lung lesion or inside the nearby bronchus at the time of their surgery. The injection is done using navigational bronchoscopy, CT-guided, or transthoracic methods depending on the tumor's location. Using a special near-infrared camera, surgeons will visualize fluorescent lymph nodes to guide their removal. After identifying sentinel lymph nodes with this imaging, the surgeon will proceed with tumor removal and standard lymph node dissection. During the study, patients will be monitored for safety and any side effects related to the ICG injection and imaging process for up to five years. Researchers will also analyze whether this imaging helps better detect metastatic disease in lymph nodes and whether the findings predict disease recurrence. Follow-up care includes standard monitoring for cancer recurrence as managed by the patient's surgeon.
CONDITIONS
Brief Title
Bronchial NIR Image-guided Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for lung surgery using video assisted thoracoscopic surgery or thoracotomy as recommended by their surgeon
- Adults aged 18 years or older
- Signed and dated informed consent obtained before any study procedures
You will not qualify if you...
- Pregnant women or women of childbearing potential without a negative pregnancy test before study procedures
- Known allergy to iodine or iodine-containing products
- Any condition that would interfere with study participation as determined by the investigator (implied from exclusion of iodine allergy and pregnancy, though not explicitly listed beyond these two in the source, so only these two exclusion criteria are included here)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate post-operative period
Participants undergo injection of near-infrared dye indocyanine green around the lung lesion or within the adjacent segmental bronchus at the time of surgery, followed by near-infrared imaging to guide lymph node removal and lung lesion resection.
1 surgical visit (in-person)
Duration - Up to 5 years
Participants are monitored by their surgeon for evidence of disease recurrence and safety after surgery.
Follow-up visits as scheduled by the surgeon
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 01224
Actively Recruiting
Research Team
Y
Yolonda Colson, MD, PhD
I
Isha Mehta Warikoo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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