Intraoperative Imaging of Thoracic Malignancies With Indocyanine Green
Conditions
Lung Neoplasms
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
Imaging, Indocyanine Green, Lung Cancer, Lung Neoplasms, Preliminary Study
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Intervention
Name: Indocyanine Green
Type: Drug
Overall Status
Recruiting
Summary
Our specific aim is to determine if Indocyanine Green (ICG) administered intraoperatively and imaged using our camera will aid in the identification of a suspected lung nodule.
Detailed Description
According to the World Health Organization, lung cancer is the most common cause of cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide annually as of 2004. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismal 53% for Stage I and 32% for Stage II1. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery with a safe non-toxic contrast agent it would be possible for the investigators to improve the rates of recurrence free patients and thus overall survival. This study is a small pilot/feasibility study to determine if the investigators camera system can be effective at identifying malignancies in lung cancer patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Adult patients over 18 years of age

2. Patients presenting with a lung nodule or mass presumed to be resectable stage I, II, or IIIa non-small call lung cancer on pre-operative assessment

3. Good operative candidate as determined by a thoracic oncology multidisciplinary team

4. Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria:

1. Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery

2. Subjects with a history of iodide allergies

3. At-risk patient populations

- Homeless patients

- Patients with drug or alcohol dependence

- Children and neonates

- Patients unable to participate in the consent process
Location
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Sunil Singhal, MD - sunil.singhal@uphs.upenn.edu
Start Date
May 2011
Completion Date
September 2016
Sponsors
University of Pennsylvania
Source
University of Pennsylvania
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page