Unique ID issued by UMIN | UMIN000025096 |
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Receipt number | R000028857 |
Scientific Title | Usefulness of FAMT-PET to predict the response after nivolumab in patients with previously treated advanced non-small cell lung cancer |
Date of disclosure of the study information | 2016/12/12 |
Last modified on | 2018/12/29 11:52:21 |
Usefulness of FAMT-PET to predict the response after nivolumab in patients with previously treated advanced non-small cell lung cancer
FAMT-PET and prediction of nivolumab in lung cancer
Usefulness of FAMT-PET to predict the response after nivolumab in patients with previously treated advanced non-small cell lung cancer
FAMT-PET and prediction of nivolumab in lung cancer
Japan |
Previously treated advanced non-small cell lung cancer
Pneumology | Hematology and clinical oncology | Radiology |
Malignancy
NO
Nivolumab, 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 FAMT-PET as a predictor of nivolumab.
Others
To monitor the outcome after treatment
Exploratory
Pragmatic
Not applicable
Changeing of SUVmax, MTV and TLG, and the efficacy of novolumab
Evaluation after 1 month from administration of nivolumab
Survival and adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Diagnosis
Medicine | Device,equipment |
All patients undergo FAMT-PET/MRI before and 4 weeks after initiation of nivolumab 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
30
1st name | |
Middle name | |
Last name | Kyoichi Kaira |
Gunma Univetsity Hospital
Oncology Clinical Development
showa-machi, Mebashi, Gunma
027-220-8222
kkaira1970@yahoo.co.jp
1st name | |
Middle name | |
Last name | Kyoichi Kaira |
Gunma Univetsity Hospital
Oncology Clinical Development
showa-machi, Mebashi, Gunma
027-220-8222
kkaira1970@yahoo.co.jp
Gunma Univetsity
Gunma Univetsity
Self funding
NO
2016 | Year | 12 | Month | 12 | Day |
Unpublished
Suspended
2016 | Year | 11 | Month | 30 | Day |
2016 | Year | 12 | Month | 05 | Day |
2018 | Year | 04 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2018 | Year | 12 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028857
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