Unique ID issued by UMIN | UMIN000026730 |
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Receipt number | R000030688 |
Scientific Title | Usefulness of FDG-PET/CT to predict the response after pembrolizumab in patients with PD-L1 positive advanced non-small cell lung cancer |
Date of disclosure of the study information | 2017/03/30 |
Last modified on | 2017/03/28 07:56:24 |
Usefulness of FDG-PET/CT to predict the response after pembrolizumab in patients with PD-L1 positive advanced non-small cell lung cancer
FDG-PET/CT and prediction of pembrolizumab in lung cancer
Usefulness of FDG-PET/CT to predict the response after pembrolizumab in patients with PD-L1 positive advanced non-small cell lung cancer
FDG-PET/CT and prediction of pembrolizumab in lung cancer
Japan |
advanced non-small cell lung cancer
Pneumology | Radiology |
Malignancy
NO
Pembrolizumab, a programmed death 1 immune checkpoint inhibitor antibody, was effective for patients with PD-L1 positive advanced NSCLC. However, the presence of promising biomarker still remains unclear. Little is known about the role of CT scan as an appropriate radiological modality. Therefore, we conducted the clinical study to evaluate FDG-PET as a predictor of pembrolizumab.
Others
To monitor the outcome after treatment
Exploratory
Pragmatic
Not applicable
Changeing of SUVmax, MTV and TLG, and the efficacy of pembrolizumab
Evaluation after 1 month from administration of pembrolizumab
Survival and adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Diagnosis
Medicine | Device,equipment |
All patients undergo FDG-PET/CT before and 4 weeks after initiation of pembrolizumab therapy.
20 | years-old | <= |
Not applicable |
Male and Female
1) Pathologically confirmed advanced non-small cell lung cancer (NSCLC), and PD-L1 positive advanced NSCLC
2) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
3) Patient with evaluable lesion based on RECIST
4) Written informed consent
1) Pregnant woman
2) Patients with obvious interstitial pneumonia or pulmonary fibrosis in the chest X-ray.
3) Patients with collagen vascular disease or autoimmune diseases
4) Other cases attending physician it is determined unsuitable for registration of the study
50
1st name | |
Middle name | |
Last name | Kyochi Kaira |
Gunma University
Oncology Clinical Development
showa-machi, Meabasshi, Gunm , Japan
027-220-8222
kkaira1970@yahoo.co.jp
1st name | |
Middle name | |
Last name | Kyochi Kaira |
Gunma University
Oncology Clinical Development
showa-machi, Meabasshi, Gunm , Japan
027-220-8222
kkaira1970@yahoo.co.jp
Gunma University Hospital
Gunma University Hospital
Self funding
NO
2017 | Year | 03 | Month | 30 | Day |
Unpublished
2017 | Year | 03 | Month | 23 | Day |
2017 | Year | 04 | Month | 01 | Day |
2017 | Year | 03 | Month | 28 | Day |
2017 | Year | 03 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030688
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