Dose Comparison Study of Intravenous ICG Dose in Lung Malignant Tumor Localization Method Using Fluorescence Spectroscopy Syste
- Conditions
- Primary lung cancer(or suspicious), or metastatic lung tumor (or suspicious)malignant lung tumor
- Registration Number
- JPRN-jRCTs011230037
- Lead Sponsor
- Kato Tatsuya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Patients who meet all of the following criteria are eligible
(1) Male and female patients aged 20 years or older at the time of consent
(2) Patients with a preoperative diagnosis of primary lung cancer (or suspected primary lung cancer)
or metastatic lung tumor (or suspected metastatic lung tumor)
(3) Patients whose tumor diameter on CT is 1 cm or greater and whose tumor is located within 2 cm
in depth from the lung surface
(4) Patients who have received a thorough explanation of their participation in this study, and who
have given their free and voluntary written consent based on a thorough understanding of the situati
on.
Patients who fall under any one of the following categories shall be excluded.
(1) Age less than 20 years old at the time of consent
(2) Patients with a history of allergy to ICG, iodineor contrast media (because ICG contains a small a
mount of iodine)
(3) Patients with interstitial pneumonia or pulmonary fibrosis evident on chest CT
(4) Pregnant or lactating mothers
(5) Patients who are abstinent or unable to use effective contraceptive methods during the period of
participation in the study
(6) Patients who have difficulty in oral intake
(7) Patients with obvious hepatic or cardiac dysfunction
(8) Patients with dementia and others who need to give their consent
(9) Other patients deemed inappropriate as resear
ch subjects by the principal investigator or subinvestigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the correct diagnosis rate for localization identification in the intravenous ICG administration method.
- Secondary Outcome Measures
Name Time Method (1) Measurement of ICG fluorescence spectral intensity in lung tumor<br>(2) Evaluation of operability and safety for intrathoracic usage<br>(3) Measurement of ICG fluorescence spectral intensity in surgical specimens<br>(4) Comparison of spectral intensities of collapsed and distended lungs<br>(5) Comparison of spectral intensity with ICG camera images<br>(6) Comparison of analysis results with histopathological examination of surgical specimens