Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bronchial NIR Image-guided Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03097575
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : November 7, 2019
Sponsor:
Collaborators:
Society of University Surgeons
Brigham and Women's Hospital
Information provided by (Responsible Party):
Yolonda Colson, MD, PhD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Sentinel Lymph Node Drug: ICG Intervention Device: Near Infrared Imaging Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Bronchial NIR Image-guided Resection, Mapping And Targeted Lymphadenectomy for Lung Lesions
Actual Study Start Date : January 6, 2015
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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:
  • NIR Lymphatic Mapping
  • Indocyanine Green

Device: Near Infrared Imaging
A near-infrared camera device will be used to detect indocyanine green following injection.




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Investigate whether SLNs can be identified using NIR-guidance following peritumoral ICG injection. [ Time Frame: 5 years ]
    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.

  2. 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 [ Time Frame: 5 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients that have agreed to undergo video assisted thoracoscopic surgery or thoracotomy for surgical resection as recommended by their thoracic surgeon.
  • N2 lymph nodes negative on PET scan or (via mediastinoscopy, transthoracic, or endobronchial ultrasound)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097575


Contacts
Layout table for location contacts
Contact: Yolonda Colson, MD, PhD 617-726-5200 ycolson@partners.org
Contact: Diane Davies, BSN 617-643-4390 ddavies@partners.org

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 01224
Contact: Yolonda L Colson, MD, PhD    617-726-5200    ycolson@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Society of University Surgeons
Brigham and Women's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yolonda L Colson, MD, PhD Massachusetts General Hospital

Layout table for additonal information
Responsible Party: Yolonda Colson, MD, PhD, Dr., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03097575    
Other Study ID Numbers: 2014P001436
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers at this time.

Layout table for additional information
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
Keywords provided by Yolonda Colson, MD, PhD, Massachusetts General Hospital:
Lung lesions
Navigational bronchoscopy
Near infrared imaging
Lymphadenectomy