This is a phase 3, multi-center, randomized, single dose, open-label study to determine the efficacy of a single dose, 5 mg/kg of ICG (TumorGlow) used with Near Infrared (NIR) fluorescent to detect clinically significant event (CSE) for subjects with suspected metastatic sarcoma to the lung scheduled to undergo thoracic surgery per CT/PET or other imaging based on standard of care. The study will also include a non-randomized pediatric cohort to evaluate the safety of 5 mg/kg ICG intravenously with NIR fluorescent light imaging in children undergoing pulmonary metastatectomy. To evaluate the efficacy of a single dose, 5 mg/kg of ICG used with Near Infrared (NIR) fluorescent imaging to detect at least one of the following clinically significant event (CSE). 1. One or more primary nodule(s) (cancerous or non-cancerous) not detected under white light and/or palpation but is detected by fluoresces imaging in situ. 2. One or more cancerous synchronous lesion(s) not detected under white light and/or palpation but is detected by fluoresces imaging. 3. The identification of a positive margin that defined as fluoresces within (i.e., less than or equal to) 5 mm of the surgical margin under fluoresces imaging.

Only patients randomized to receiving NIR fluoresces imaging will be included in the analyses of the primary objective. 1.      To estimate the sensitivity of in-situ NIR fluorescence imaging against the assessment by back table NIR imaging. 
2.      To estimate the sensitivity of NIR fluorescence imaging against the assessment by pathology. 
3.      To estimate the false positive rate of in-situ NIR fluorescence imaging against the assessment by back table NIR imaging.
4.      To estimate the false positive rate of NIR fluorescence imaging against the assessment by pathology. 
5.      To evaluate the proportion of subjects whose surgical procedure changed in scope from the planned surgery to the surgery performed based on the use of ICG with NIR fluorescent imaging.
6.      To evaluate the time to localization of the primary nodule under white light and palpation alone compared to the time of localization after adding NIR fluorescence imaging in the group randomized to imaging.
7.      To evaluate the proportion of lesions noted on pre-operative imaging detected by NIR fluorescence imaging that are not detected by white light and/or palpation alone.
8.      To evaluate the proportion of metastatic cancerous synchronous lesions identified by NIR fluorescence imaging in an anatomical portion of the lung that was not in the planned surgical resection.
9.      To compare the proportion of patients with CSE by open thoracotomy versus video assisted thoracoscopic surgery (VATS).
10.     To compare the Tumor to Background Ratios (TBR) by histological subtypes and clinical parameters.
11.     Only subjects randomized to receiving NIR fluoresces will be included in the analyses for the secondary efficacy objective described. 
12.     To access the safety and tolerability of intravenously infusion of a single dose 5 mg/kg of ICG. 
13.      To accessTo evaluate the safety of using high dose (5 mg/kg) ICG used with Near Infrared (NIR) fluorescent imaging when used with ICG. in pediatric patients undergoing pulmonary metastatectomy

You may be eligible for this study if you meet the following criteria:

• Conditions: Medical Research
• Age: - 99 Years
• Gender: All