Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Dana-Farber Cancer Institute
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Yolonda L. Colson, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00264602
First received: December 12, 2005
Last updated: February 9, 2015
Last verified: February 2015
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Purpose
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 analysis to improve the ability to detect tumor in this node and to remove this additional site that potentially contains tumor cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Procedure: Near Infrared Imaging |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 114 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Procedure: Near Infrared Imaging
Dye injected into or around tumor at the time of surgery
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264602
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264602
Contacts
| Contact: Yolonda L. Colson, MD, PhD | 617-732-6648 | ycolson@partners.org |
Locations
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Investigators
| Principal Investigator: | Yolonda L. Colson, MD, PhD | Brigham and Women's Hospital |
More Information
No publications provided
| 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 |
| Study First Received: | December 12, 2005 |
| Last Updated: | February 9, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
Lymphatic mapping nodal targeting indocyanine green near infrared imaging |
ClinicalTrials.gov processed this record on March 03, 2015