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OpenTrials
Completed

NCT Number: NCT01335893

Intraoperative Imaging of Thoracic Malignancies With Indocyanine Green

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients over 18 years of age
  • 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
  • Good operative candidate as determined by a thoracic oncology multidisciplinary team
  • Subject capable of giving informed consent and participating in the process of consent

Exclusion criteria

  • Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
  • Subjects with a history of iodide allergies
  • At-risk patient populations
  • Homeless patients
  • Patients with drug or alcohol dependence
  • Children and neonates
  • Patients unable to participate in the consent process

Treatment and study plan

Indocyanine green

Drug

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

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 14, 2011
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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