Bronchial NIR Image-guided Resection

Bronchial NIR Image-guided Resection, Mapping And Targeted Lymphadenectomy for Lung Lesions

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.

Study Overview

• Status: Recruiting
• Conditions: Sentinel Lymph Node
• Intervention / Treatment: Drug: ICG Intervention; Device: Near Infrared Imaging

Detailed Description

Patients enrolled in the study will undergo peritumoral injection of near-infrared dye indocyanine green around the lung lesion or within the adjacent segmental bronchus at the time of surgery. ICG injection will be carried out via navigational bronchoscopy, CT-guided or trans-thoracic ICG injection (dependent on lesion location) and ICG imaging of the sentinel lymph nodes will be undertaken using an NIR-enabled camera.

• This study is designed primarily to determine the safety and feasibility of intra-operative localization of thoracic lesions following ICG injection, and second, to include an assessment of the predictive value of sentinel lymph nodes relative to the disease status of the greater lymphadenectomy specimen as well as disease recurrence rates.
• We are using a dose approximately 100 times lower than previously approved for injection in the blood. After a few minutes, the surgeon will look at these lymph nodes with near-infrared fluorescence and then remove any fluorescent and non-fluorescent lymph nodes near the tumor, as is standard for lung surgery.
• The "filtered" near-infrared light causes the indocyanine green dye to fluoresce so that the surgeon can identify the lymph nodes most likely to contain tumor cells. If the lymph node is not found in the group of nodes usually removed, we will use the near-infrared light to look near the tumor for the sentinel lymph nodes and guide the surgeon so that the sentinel nodes can be removed and studied. The surgeon will then continue with the operation and remove the tumor. The lymph nodes are processed for special analysis tailored to finding metastasis in sentinel lymph nodes.
• As is standard of care, patients will be monitored for evidence of recurrence by their surgeon. Recurrences will be recorded.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yolonda Colson, MD, PhD; Phone Number: 617-726-5200; Email: ycolson@partners.org
• Study Contact Backup: Name: Isha Mehta Warikoo, MD; Phone Number: 18572501355; Email: imehtawarikoo@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 01224
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Yolonda L Colson, MD, PhD; Phone Number: 617-726-5200; Email: ycolson@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Drug: 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.; Other Names: Indocyanine Green; NIR Lymphatic Mapping; Device: Near Infrared Imaging; A near-infrared camera device will be used to detect indocyanine green following injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate whether SLNs can be identified using NIR-guidance following peritumoral ICG injection.	Technical difficulty and clinical complications have resulted in < 50% of surgeons performing complete removal of tumor draining lymph nodes at the time of surgery. Therefore, we will assess the feasibility of SLN identification following ICG injection for "targeted" lymph node sampling and focused analysis staging. This Outcome will be addressed only in cases where a lymphadenectomy is performed.	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	Studies in stage I and II lung cancer have demonstrated "occult" nodal metastatic disease affects clinical outcomes, however, currently there is no accurate means to identify micrometastatic nodal disease in these patients prospectively. Therefore, we will analyze the SLN results to determine whether prospectively identified "occult" micrometastatic disease in the SLN is a "predictor" of disease recurrence. This Outcome is pertinent only to cases in which a lymphadenectomy was performed.	5 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Brigham and Women's Hospital; Society of University Surgeons
• Investigators: Principal Investigator: Yolonda L Colson, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2015
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Lymphadenectomy; Near infrared imaging; Lung lesions; Navigational bronchoscopy
• Other Study ID Numbers: 2014P001436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make IPD available to other researchers at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes