Status:

ACTIVE_NOT_RECRUITING

Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer

Lead Sponsor:

Dana-Farber Cancer Institute

Collaborating Sponsors:

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

The primary purpose of this study is to determine if we can 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 a...

Detailed Description

* This study is designed to determine the feasibility, safety amd dosing for indocyanine green and near-infrared fluorescent light in order to maximize the near infrared-guided detection of tumor-spec...

Eligibility Criteria

Inclusion

  • Suspected or histologically documented new non-small cell carcinoma that have agreed to undergo a thoracotomy for segmentectomy, lobectomy, bilobectomy or pneumonectomy as recommended by their thoracic surgeon for treatment
  • Surgically resectable lung cancer
  • N2 lymph nodes negative on PET scan or mediastinoscopy
  • Age \> or equal to 18 years of age
  • Men, women of non-child bearing age or women with a negative pregnancy test

Exclusion

  • Patient does not want to undergo subsequent surgical resection
  • Medical condition such as uncontrolled infection or cardiac disease that, i the opinion of the treating surgeon, makes resection unreasonably hazardous for the patient.
  • T4 or N2 disease
  • Pre-operative spirometry that suggests they cannot undergo resection of their primary tumor by segmentectomy, lobectomy, bilobectomy, or pneumonectomy
  • Iodide or seafood allergy
  • Pregnant or lactating women

Key Trial Info

Start Date :

February 18 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2029

Estimated Enrollment :

57 Patients enrolled

Trial Details

Trial ID

NCT00264602

Start Date

February 18 2009

End Date

December 1 2029

Last Update

November 7 2025

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

2

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02115

3

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

4

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02115