Intraoperative Imaging of Thoracic Malignancies With Indocyanine Green



Status:Completed
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/7/2018
Start Date:May 2011
End Date:December 14, 2014

Use our guide to learn which trials are right for you!

A Phase 1, Open-Label, Single Center Study of the Imaging Potential of Indocyanine Green in Subjects Undergoing Thoracic Surgery Presenting With Lung Nodules

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.

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.

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
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Sunil Singhal, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials