臨床研究等提出・公開システム

Dose Comparison Study of Intravenous ICG Dose in Lung Malignant Tumor Localization Method Using Fluorescence Spectroscopy Syste (Identification of Lung Malignant Tumors with a spectral device using the ICG intravenous administration method)

Dose Comparison Study of Intravenous ICG Dose in Lung Malignant Tumor Localization Method Using Fluorescence Spectroscopy Syste (Identification of Lung Malignant Tumors with a spectral device using the ICG intravenous administration method)

Kato Tatsuya

Hokkaido University Hospital

Kita 14, nishi 5, Kita-ku, Sapporo, Hokkaido

thoracicsurg@pop.med.hokudai.ac.jp

Ujiie Hideki

Hokkaido University Hospital

Kita 14, nishi 5, Kita-ku, Sapporo, Hokkaido

+81-11-706-6009

hideki.ujiie.md@gmail.com

Recruiting

Sept. 11, 2023

Interventional

non-randomized controlled trial

open(masking not used)

dose comparison control

parallel assignment

diagnostic purpose

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.

Both

Primary lung cancer(or suspicious), or metastatic lung tumor (or suspicious)

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 0.5 mg/kg. If the positive diagnosis rate is low, the dose should be gradually increased up to 5.0 mg/kg to determine the optimal dose for tumor detection.
In the ICG camera used inside the body during surgery, there is a possibility that other lesions (such as pleural dissemination) that are not indicated in the preoperative examination may be detected. Based on these findings, it is possible to consider changing the surgical method and treatment policy intraoperatively as part of clinical practice and change the surgical method (change to biopsy or reduced surgery).

malignant lung tumor

Localization and diagnosis of lung malignant tumors

C08

E01

Evaluation of the correct diagnosis rate for localization identification in the intravenous ICG administration method.

(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

+81-11-706-7934

Aug. 24, 2023

none