Recruiting
Phase 1
Phase 2

NIR Image-guided Resection

Sponsor:

Massachusetts General Hospital

Code:

NCT03097575

Conditions

Sentinel Lymph Node

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ICG Intervention

Near Infrared Imaging

Study Details

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

Study ID

NCT03097575

Start date

Jan 6, 2015

Status verified date

Nov, 2025

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: ICG Intervention

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.

Interventions

ICG Intervention

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.

Near Infrared Imaging

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Yolonda Colson, MD, PhD

617-726-5200ycolson@partners.org

Isha Mehta Warikoo, MD

18572501355imehtawarikoo@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 01224

Contacts

Yolonda L Colson, MD, PhD

617-726-5200ycolson@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • Lung lesions
  • Navigational bronchoscopy
  • Near infrared imaging
  • Lymphadenectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-10.