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Bronchial NIR Image-guided Resection for Lung Lesions

This study is testing a new way to find lung lesions and sentinel lymph nodes (the first lymph nodes that drain from a tumor) during surgery. It uses a special dye called indocyanine green (ICG) and a near-infrared camera. The ICG is injected around the lung lesion or in the nearby airway before surgery. The camera then helps the surgeon see the dye, which highlights the lung lesion and lymph nodes that might contain cancer cells. The main goal is to see if this method is safe and practical for guiding surgeons. You can join if you are 18 or older and are scheduled for lung surgery. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 100 participants. It is designed to evaluate the safety and feasibility of using ICG with near-infrared imaging.
What's involved
You will receive an injection of indocyanine green dye around your lung lesion or in the adjacent airway during your scheduled surgery. A near-infrared camera will then be used to detect the dye.
Compensation
Not stated in the trial record.
Follow-up
The incidence of adverse events will be measured for up to 5 years after treatment.

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NCT03097575

Bronchial NIR Image-guided Resection

Recruiting
PHASE1Ages 18+Interventional
Massachusetts General Hospital
~100 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:ICG InterventionNear Infrared Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events (safety and feasibility) of intraoperative NIR-image-guided localization of lung lesions using peritumoral ICG injection.
Measured over 5 years

Conditions

Sentinel Lymph Node

Explore related trials

Lung Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Yolonda L Colson, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Yolonda Colson, MD, PhD
[email protected]
617-726-5200
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence of treatment-emergent adverse events (safety and feasibility) of intraoperative NIR-image-guided localization of lung lesions using peritumoral ICG injection.5 years

    In this initial proof-of-concept pilot trial for patients undergoing surgical resection of a suspicious lung lesion, we will translate the new technology of NIR-imaging to the OR and assess safety and feasibility of ICG delivery, optimize the ability to "NIR tattoo" and visualize lung lesions for targeted resection vs NIR-highlighted segmental resections, assess histology of the surgical margin and determine lesional characteristics which predict successful NIR imaging. Safety and feasibility will be measured quantitatively by the number of participants with treatment-related adverse events, as assessed by CTCAE v4.0.