Real-Time Image Guided Lymphatic Mapping and Nodal Targeting in Lung Cancer
Status: Recruiting
Phase: Phase 1
Diagnosis: Lung Cancer
NCT ID: NCT00264602
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 05-219
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.
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center
Overall PI:
Yolanda Colson, MD,
Brigham and Women's Hospital
Site-responsible Investigators:
Contacts:
Brigham and Women's Hospital:
Onkar Khullar, MD, 617-732-8695,
okhullar@partners.org
Eligibility 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
- Clinical Stage I or II proven or suspected lung cancer
- T1 or T2 primary
- 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.
- T3N0 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