Bronchial NIR Image-guided Resection

Description

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 Start Date

January, 06 2015

Estimated Completion Date

January 2021

Interventions

  • Device: Near Infrared Imaging
  • Drug: ICG Intervention

Study ID

Brigham and Women's Hospital -- 2014P001436

Status

Recruiting

Trial ID

NCT03097575

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

100

Sponsor

Brigham and Women's Hospital

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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Yolonda Colson MD PhD 617-732-5500 ycolson@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Yolonda Colson MD PhD 617-732-5500 ycolson@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Yolonda Colson MD PhD 617-732-5500 ycolson@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Yolonda Colson MD PhD 617-732-5500 ycolson@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Yolonda Colson MD PhD 617-732-5500 ycolson@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Yolonda Colson MD PhD 617-732-5500 ycolson@partners.org

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