Clinical trial NCT01335893: Intraoperative Imaging of Thoracic Malignancies With Indocyanine Green
Official title: A Phase 1, Open-Label, Single Center Study of the Imaging Potential of Indocyanine Green in Subjects Undergoing Thoracic Surgery Presenting With Lung Nodules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Neoplasms
Keywords: Imaging
Indocyanine Green
Lung Cancer
Lung Neoplasms
Preliminary Study
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2011-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility 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

Primary outcomes:
measure: Imaging effectiveness of ICG and imaging system.
timeFrame: 1 day after injection of ICG
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sunil Singhal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Okusanya OT, Holt D, Heitjan D, Deshpande C, Venegas O, Jiang J, Judy R, DeJesus E, Madajewski B, Oh K, Wang M, Albelda SM, Nie S, Singhal S. Intraoperative near-infrared imaging can identify pulmonary nodules. Ann Thorac Surg. 2014 Oct;98(4):1223-30. doi: 10.1016/j.athoracsur.2014.05.026. Epub 2014 Aug 5.