Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer
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ClinicalTrials.gov Identifier: NCT00264602 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 13, 2005
Last Update Posted
: December 20, 2017
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Condition or disease | Intervention/treatment | Phase |
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Lung Cancer | Drug: Near Infrared Imaging | Phase 1 |
- 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-specific sentinel lymph nodes during the routine surgery for early stage lung cancer when the tumor and nearby lymph nodes are removed.
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 57 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Masking Description: | There is no masking in this study. All study subjects will receive the same intervention. |
Primary Purpose: | Diagnostic |
Official Title: | Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer |
Actual Study Start Date : | February 18, 2009 |
Actual Primary Completion Date : | September 1, 2017 |
Estimated Study Completion Date : | January 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Near Infrared Imaging
The intervention to be administered is indocyanine green dye.
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Drug: Near Infrared Imaging
Dye injected into or around tumor at the time of surgery
Other Names:
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- To evaluate the safety and efficacy of near-infrared technology to guide therapeutic sentinel lymph node dissection in patients with lung cancer. [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

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): NCT00264602
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Yolonda L. Colson, MD, PhD | Brigham and Women's Hospital |
Responsible Party: | Yolonda L. Colson, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00264602 History of Changes |
Other Study ID Numbers: |
05-219 |
First Posted: | December 13, 2005 Key Record Dates |
Last Update Posted: | December 20, 2017 |
Last Verified: | December 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Yolonda L. Colson, MD, PhD, Dana-Farber Cancer Institute:
Lymphatic mapping nodal targeting indocyanine green near infrared imaging |
Additional relevant MeSH terms:
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |