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Intraoperative Imaging of Thoracic Malignancies With Indocyanine Green

This study is currently recruiting participants.
Verified January 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Sunil Singhall, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01335893
First received: April 1, 2011
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Lung Neoplasms
 Drug: Indocyanine Green
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Imaging effectiveness of ICG and imaging system. [ Time Frame: 1 day after injection of ICG ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 10
Study Start Date: May 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICG injection group
This group will receive a single dose of 5mg/Kg, diluted in saline solution, prior to surgery. Then, during their surgery, they will be imaged with the camera and imaging probe we have developed.
 Drug: Indocyanine Green
Dose will be 5mg/kg, diluted in saline solution. This will be a single dose given before the surgery intravenously.
Other Names:
  • ICG
  • Indocyanine Green USP, for injection

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335893

Contacts
Contact: Sunil Singhal, M.D. 215-573-9918 sunil.singhal@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sunil Singhal, MD         sunil.singhal@uphs.upenn.edu    
Principal Investigator: Sunil Singhal, MD            
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Sunil Singhal, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Sunil Singhall, MD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01335893     History of Changes
Other Study ID Numbers: UPCC:11510
Study First Received: April 1, 2011
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Imaging
Indocyanine Green
Lung Cancer
Lung Neoplasms
Preliminary Study

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013