Lung Cancer Clinical Trial

Intraoperative Imaging of Thoracic Malignancies With Indocyanine Green

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Adult patients over 18 years of age
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
Good operative candidate as determined by a thoracic oncology multidisciplinary team
Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria:

Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
Subjects with a history of iodide allergies

At-risk patient populations

Homeless patients
Patients with drug or alcohol dependence
Children and neonates
Patients unable to participate in the consent process

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT01335893

Recruitment Status:

Completed

Sponsor:

University of Pennsylvania

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There is 1 Location for this study

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University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

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Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT01335893

Recruitment Status:

Completed

Sponsor:


University of Pennsylvania

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