Near‑infrared guided removal of lung nodules and sentinel lymph nodes
Official title: Bronchial NIR Image-guided Resection, Mapping And Targeted Lymphadenectomy for Lung Lesions
Run by Massachusetts General Hospital · NCT03097575 · Data updated 2026-11-12
This will test whether injecting a tiny amount of near‑infrared dye near a lung nodule helps surgeons find and remove the nodule and the first draining (sentinel) lymph node in adults having lung surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | January 6, 2015 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2029 |
| Registry record updated | November 10, 2025 |
| Trial ID | NCT03097575 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who consent and are scheduled for VATS or thoracotomy to surgically remove a lung lesion, and who are not pregnant and have no iodine allergy, are the ideal candidates.
✕Probably not a fit
Patients who are pregnant, have an iodine allergy, have lesions that cannot be accessed by bronchoscopic/CT/transthoracic injection, or who have widely metastatic disease are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients scheduled for lung nodule resection will receive a peritumoral injection of indocyanine green (ICG) via navigational bronchoscopy, CT‑guided, or transthoracic approach depending on lesion location. Surgeons will use a near‑infrared (NIR) camera during the operation to visualize fluorescent nodules and sentinel lymph nodes and will remove fluorescent and standard lymph nodes for pathological analysis. The primary goal is to determine the safety and feasibility of intraoperative localization using a low ICG dose, and a secondary goal is to compare sentinel node status to the full lymphadenectomy specimen and monitor recurrence. The procedure uses an ICG dose much lower than typical intravenous doses and is performed alongside standard surgical practice rather than replacing it.
Why it matters
Potential benefit: If successful, this technique could help surgeons identify tumors and the first draining lymph node more reliably, improving staging accuracy and guiding more precise removal of cancerous tissue.
How similar studies have gone: ICG and NIR mapping have shown feasibility and useful sentinel node localization in other cancers and some thoracic feasibility reports exist, but bronchoscopic peritumoral ICG for lung sentinel node mapping is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Yolonda L Colson, MD, PhD — Massachusetts General Hospital
- Study coordinator: Yolonda Colson, MD, PhD
- Email: ycolson@partners.org
- Phone: 617-726-5200
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.