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Intraoperative Imaging of Thoracic Malignancies With Indocyanine Green

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ClinicalTrials.gov Identifier: NCT01335893
Recruitment Status : Recruiting
First Posted : April 14, 2011
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Drug: Indocyanine Green Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Start Date : May 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ICG injection group
This group will receive a single dose of ICG, 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 diluted in saline solution. This will be a single dose given before the surgery intravenously.
Other Names:
  • ICG
  • Indocyanine Green USP, for injection


Outcome Measures

Primary Outcome Measures :
  1. Imaging effectiveness of ICG and imaging system. [ Time Frame: 1 day after injection of ICG ]
    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).


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01335893     History of Changes
Other Study ID Numbers: UPCC:11510
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

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

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