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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lung Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Imaging effectiveness of ICG and imaging system.

Outcome Description:

The primary end-point of the study is to determine the sensitivity of ICG uptake and expression in identifying lung nodules / masses when excited by an imaging probe intraoperatively. This will be accomplished by using the probe to image the tumor, then subtracting the background from surrounding thoracic structures. Uptake will be measured using the scale of the instrument, an arbitrary value of between 1 and 10,000. Uptake will be summarized using the mean and 95% confidence interval (CI).

Outcome Time Frame:

1 day after injection of ICG

Safety Issue:

No

Principal Investigator

Sunil Singhal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC:11510

NCT ID:

NCT01335893

Start Date:

May 2011

Completion Date:

September 2016

Related Keywords:

  • Lung Neoplasms
  • Imaging
  • Indocyanine Green
  • Lung Cancer
  • Lung Neoplasms
  • Preliminary Study
  • Neoplasms
  • Lung Neoplasms

Name

Location
University of Pennsylvania Philadelphia, Pennsylvania  19104