Near Infrared Imaging for Sentinel Lymph Node Identification
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a special dye called indocyanine green (ICG) to help doctors better visualize lung tumors during surgery. The dye helps locate and remove the first lymph node that may indicate cancer spread. This technique aims to enhance the identification and removal of lung tumors. Suitable participants have agreed to undergo lung surgery as recommended by their doctor. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this technique is safe for identifying lung lesions and sentinel lymph nodes?
Research has shown that indocyanine green (ICG) has been safely used for over 30 years in medical tests for heart and liver functions, indicating a good safety record. However, some individuals might experience side effects, such as nausea or stomach discomfort. More serious allergic reactions, like anaphylaxis, are rare but possible. Anaphylaxis is a severe allergic reaction that requires immediate medical attention.
The liver mainly processes ICG, so individuals with liver problems might face a higher risk of the drug accumulating in their system, potentially leading to harmful effects. For most people, though, ICG is well-tolerated. Awareness of these potential risks, even if uncommon, remains important.12345Why are researchers excited about this trial?
Unlike the standard of care for bronchial conditions, which often involves conventional surgical methods and imaging techniques, the new approach being studied uses indocyanine green (ICG) for near-infrared (NIR) lymphatic mapping during resection. This method allows surgeons to visualize lymphatic structures with greater precision, potentially leading to more accurate and effective surgeries. Researchers are excited about this technique because it could minimize unnecessary tissue removal and improve patient recovery times, making surgeries less invasive and more targeted.
What evidence suggests that this technique is effective for identifying lung lesions and sentinel lymph nodes?
Research shows that indocyanine green (ICG), which participants in this trial will receive, helps doctors locate lymph nodes more accurately when used with near-infrared (NIR) imaging. Studies have demonstrated that ICG effectively maps these nodes, which is crucial during surgeries to ensure the removal of all cancer cells. This technique enhances the surgeon's ability to see and remove the correct nodes, improving cancer detection. Other research has shown that ICG successfully highlights lymphatic pathways, making surgeries more precise. These findings suggest that ICG improves surgical outcomes by better identifying important areas.678910
Who Is on the Research Team?
Yolonda L Colson, MD, PhD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for patients set to have lung surgery (video assisted thoracoscopic surgery or thoracotomy) as recommended by their surgeon. They must understand and agree to the study's procedures, which will be explained in a consent form they need to sign and date before starting.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo peritumoral injection of near-infrared dye indocyanine green and subsequent surgical resection of lung lesions
Follow-up
Participants are monitored for safety and effectiveness after treatment, including recurrence monitoring
What Are the Treatments Tested in This Trial?
Interventions
- ICG
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Society of University Surgeons
Collaborator
Brigham and Women's Hospital
Collaborator