Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer
NCT ID: NCT00264602
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
57 participants
INTERVENTIONAL
2009-02-18
2029-12-01
Brief Summary
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Detailed Description
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* At the time of surgery, the indocyanine dye will be injected into or around the patient's tumor. We are using a dose approximately 10,000 times lower than previously approved for injection in the blood. After a few minutes, the surgeon will remove the lymph nodes near the tumor, as is standard for lung surgery, and we will look at these lymph nodes with near-infrared fluorescence.
* 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.
* Since the first question of this study is to determine the smallest dose of indocyanine green that can be used safely for near-infrared detection of the lymph nodes, not all subjects will receive the same dose. The most any person will receive is 1/3 of a teaspoon.
* A five year observation period begins following the operation during which surgeons and physicians will examine the patient and order certain studies to look for evidence of regrowth of the tumor.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Near Infrared Imaging
The intervention to be administered is indocyanine green dye.
Near Infrared Imaging
Dye injected into or around tumor at the time of surgery
Interventions
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Near Infrared Imaging
Dye injected into or around tumor at the time of surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Massachusetts General Hospital
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Yolonda Colson, MD, PhD
Principal Investigator
Principal Investigators
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Yolonda L. Colson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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05-219
Identifier Type: -
Identifier Source: org_study_id