Primary lung cancer(or suspicious), or metastatic lung tumor (or suspicious) malignant lung tumor
Conditions
Interventions
Dissolve indocyanine green in the solution provided or in distilled water and administer intravenously the day before surgery (approximately 24 hours before the procedure). The initial dose should be
Localization and diagnosis of lung malignant tumors
Sponsors
Kato Tatsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the correct diagnosis rate for localization identification in the intravenous ICG administration method. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Measurement of ICG fluorescence spectral intensity in lung tumor (2) Evaluation of operability and safety for intrathoracic usage (3) Measurement of ICG fluorescence spectral intensity in surgical specimens (4) Comparison of spectral intensities of collapsed and distended lungs (5) Comparison of spectral intensity with ICG camera images (6) Comparison of analysis results with histopathological examination of surgical specimens | — |
Contacts
Public ContactHaruhiko Shiiya
Hokkaido University Hospital
Outcome results
None listed