Lung cancer
Conditions
Interventions
To perform an examination for FDG-PET/CT after start of therapy two cycles of the immune checkpoint inhibitor targeting at patients with lung cancer in three institutions.
Sponsors
Hyogo College of Medicine
Kindai University, Osaka university, Gunma Prefectural College of Health Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The one that fulfills all the following conditions -The which the chief physician made checkpoint inhibitor start of therapy of immunity, and judged an examination for FDG-PET/CT after two cycles if necessary -The person who received an examination for FDG-PET/CT before checkpoint inhibitor start of therapy of immunity - one 20 years or older - The good one where is from head to foot in a state - The one where treatment is planned sequentially in each facility - Outpatient department, hospitalization, the sex do not matter - The one where I can understand study contents, and a written agreement is provided
Exclusion criteria
Exclusion criteria: - That cannot keep a posture of facing upward because of pains in succession for around 30 minutes - During the pregnancy or pregnancy with the possibility - The extreme claustrophobia - The one where progress after treatment being refused, and curing became unidentified - In addition, the person who judges that a manager for study is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Right curative effect judgment best overall response which stands on the progress in various indexes (if before treatment checkpoint inhibitor treatment of immunity ago rate of change after two cycles, three ways after two cycles) such as the texture analysis (Entropy, Homogeneity, Dissimilarity, Intensity variability, Size-zone variability, Zone percentage) to express SUVmax, SUVmean, SUVpeak, SULpeak, MTV (metabolic tumor volume), TLG (total lesion glycolysis) which are a fixed-quantity level of the PET, inhomogeneity of the accumulation, and totals it clinically, and is judged: I investigate the useful index that can predict BOR (Responder vs. non-responder), convalescence (Progression free survival: PFS and Overall survival: the OS), the onset of side effect (thyroidal dysfunction, stroma-related pneumonia, exanthem, colitis) and perform the construction of the nomogram predicting outcome using a meaningful factor provided for a multivariate analysis of the survival analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| With a curative effect judgment (with EORTC classification and PERCIST classification imPERCIST classification) of the PET when compared after two cycles if was before treatment a curative effect judgment (RECIST1.1 classification and irRECIST classification and iRECIST classification) of the CT compare it, and inspect neither difference. I inspect whether a difference is reflected on PFS and the OS in Responder group (CR or CMR+PMR) and Non-responder group (PMR+SMD+PMD or SMD+PMD). | — |
Countries
Japan
Contacts
Public ContactKazuhiro Kitajima
Hyogo College of Medicine Radiology
Outcome results
None listed