Lung Neoplasms Clinical Trial
Official title:
Near-Infrared Perfusion During Minimally Invasive Thoracic Surgery
This will be a prospective, (NSR), single-center feasibility study of the Olympus VE2 NIR Imaging System to assess perfusion using NIR during minimally invasive esophagectomy and pulmonary segmentectomy. The aims of the study are: 1. To utilize NIR intraoperative imaging with the Olympus VE2 NIR Imaging System to: i. Characterize gastric conduit perfusion during esophagectomy and, ii. Identify segmental anatomy during sublobar pulmonary resection (segmentectomy) after intraoperative, intravenous delivery of low-dose 0.15 mg/kg of ICG.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | March 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: -Subject has a suspicious lung lesion for which a minimally invasive segmentectomy is planned -OR- sub-ject has an esophageal lesion for which an esophagectomy is planned - - Subject is 18 years of age or older - Subject is willing and able to provide informed consent Exclusion Criteria: - Subject is not eligible for surgical resection as determined by the treating physician - Subject has known or suspected allergy to Iodine, shellfish or intravenous contrast - Subject is not eligible or considered high risk for surgical resection as determined by pre-operative spirometry - Subject is female and of childbearing age who is currently pregnant or who is planning to become pregnant within the study - Subject is unable and unwilling to provide informed consent - Subject has liver disease or is taking drugs impact liver metabolism. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Olympus |
United States,
DeLong JC, Kelly KJ, Jacobsen GR, Sandler BJ, Horgan S, Bouvet M. The benefits and limitations of robotic assisted transhiatal esophagectomy for esophageal cancer. J Vis Surg. 2016 Sep 8;2:156. doi: 10.21037/jovs.2016.09.01. eCollection 2016. Review. — View Citation
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To utilize NIR intraoperative imaging with the Olympus VE2 NIR Imaging System for esophagectomy patients. | Fluorescent intensity, visualization of the intersegmental plane with NIR imaging, image quality will all be ranked by the surgeon as "below standard, average, or good" compared to the standard of care as they identify segmental anatomy during sublobar pulmonary resection (segmentectomy) after intraoperative, intravenous delivery of low-dose 0.15 mg/kg of ICG. | During surgery | |
Primary | To utilize NIR intraoperative imaging with the Olympus VE2 NIR Imaging System for segmentectomy patients. | Fluorescent intensity, visualization of the intersegmental plane with NIR imaging, image quality will all be ranked by the surgeon as "below standard, average, or good" compared to the standard of care as they identify esophageal anatomy during esophagectomy after intraoperative, intravenous delivery of low-dose 0.15 mg/kg of ICG. | During surgery |
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