Unique ID issued by UMIN | UMIN000031009 |
---|---|
Receipt number | R000035402 |
Scientific Title | Usefulness of FDG-PET/CT to predict the response after anti-PD-1 antibody in patients with previously treated advanced non-small cell lung cancer: a multi-institutional study |
Date of disclosure of the study information | 2018/01/27 |
Last modified on | 2018/01/26 00:24:51 |
Usefulness of FDG-PET/CT to predict the response after anti-PD-1 antibody in patients with previously treated advanced non-small cell lung cancer: a multi-institutional study
FDG-PET/CT and prediction of anti-PD-1 antibody in lung cancer
Usefulness of FDG-PET/CT to predict the response after anti-PD-1 antibody in patients with previously treated advanced non-small cell lung cancer: a multi-institutional study
FDG-PET/CT and prediction of anti-PD-1 antibody in lung cancer
Japan |
Previously treated advanced non-small cell lung cancer
Pneumology | Radiology |
Malignancy
NO
Nivolumab or Pembrolizumab, a programmed death 1 immune checkpoint inhibitor antibody, was effective for patients with previously treated 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 nivolumab.
Others
To monitor the outcome after treatment
Confirmatory
Pragmatic
Not applicable
Changeing of SUVmax, MTV and TLG, and the efficacy of anti-PD-1 antibody such as nivolumab or pembrolizumab.
Evaluation after 4weeks and 9weeks from administration of anti-PD-1 antibody.
Overall survival and progression-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Diagnosis
Medicine | Device,equipment |
All patients undergo FDG-PET/MRI before and 4 weeks and 9weeks after initiation of anti-PD-1 antibody therapy.
20 | years-old | <= |
Not applicable |
Male and Female
1) Pathologically confirmed advanced non-small cell lung cancer (NSCLC), and one or more prior systemic treatment regimens for 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
120
1st name | |
Middle name | |
Last name | Kyochi Kaira |
Gunma Univetsity Hospital
Inovative medical research center
3-39-15, showa-machi, Mebashi, Gunma
027-220-8147
kkaira1970@yahoo.co.jp
1st name | |
Middle name | |
Last name | Kyochi Kaira |
Gunma Univetsity Hospital
Inovative medical research center
3-39-15, showa-machi, Mebashi, Gunma
027-220-8147
kkaira1970@yahoo.co.jp
Gunma University
Nihon Medi-Physics Co., Ltd.
Profit organization
NO
2018 | Year | 01 | Month | 27 | Day |
Unpublished
Preinitiation
2018 | Year | 01 | Month | 24 | Day |
2018 | Year | 02 | Month | 01 | Day |
2018 | Year | 01 | Month | 26 | Day |
2018 | Year | 01 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035402
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |