Intraoperative Imaging of Thoracic Malignancies With Indocyanine Green
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|ClinicalTrials.gov Identifier: NCT01335893|
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms||Drug: Indocyanine Green||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||May 2011|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 14, 2014|
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.
- 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).
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
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Sunil Singhal, MD||University of Pennsylvania|