Bronchial NIR Image-guided Resection

NCT03097575 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2014P001436
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sentinel Lymph Node

Keywords

Lung lesions; Navigational bronchoscopy; Near infrared imaging; Lymphadenectomy

Outcome Measures

Primary Outcomes (1)

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

  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.

  5 years

Secondary Outcomes (2)

• Investigate whether SLNs can be identified using NIR-guidance following peritumoral ICG injection.

  5 years

• Assess if NIR image-guided SLN excision enhances detection of metastatic disease and whether the presence of untreated occult metastatic disease/mutational analysis of primary tumors/secondary sites of disease including SLNs are predictors of outcome

  5 years

Study Arms (1)

ICG Intervention

EXPERIMENTAL

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.

Drug: ICG Intervention; Device: Near Infrared Imaging

Interventions

ICG Intervention DRUG

Patients enrolled in the study will undergo injection of near infrared dye indocyanine green around the lung lesion or within the adjacent segmental bronchus at the time of surgery via navigational bronchoscopy, or if not amenable to navigational bronchoscopy injection, then injection will be carried out via a transthoracic approach through the incision or under CT-guidance.

Also known as: NIR Lymphatic Mapping, Indocyanine Green

ICG Intervention

Near Infrared Imaging DEVICE

A near-infrared camera device will be used to detect indocyanine green following injection.

ICG Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that have agreed to undergo video assisted thoracoscopic surgery or thoracotomy for surgical resection as recommended by their thoracic surgeon.
• years of age or older
• Documented, signed, dated informed consent obtained prior to any study specific procedures being performed

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Society of University Surgeons: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 01224, United States

RECRUITING

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yolonda L Colson, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yolonda Colson, MD, PhD

CONTACT

617-726-5200; ycolson@partners.org

Isha Mehta Warikoo, MD

CONTACT

18572501355; imehtawarikoo@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 31, 2017
• Study Start: January 6, 2015
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)