| 基本情報/Basic information |
| 一般向け試験名/Public title |
既治療非小細胞肺癌に対するニボルマブ療法の効果予測におけるFDG-PET/MRIの有用性の検討 |
FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer |
| 一般向け試験名略称/Acronym |
肺癌に対するニボルマブ療法の効果予測におけるFDG-PET/MRIの有用性の検討 |
FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer |
| 科学的試験名/Scientific Title |
既治療非小細胞肺癌に対するニボルマブ療法の効果予測におけるFDG-PET/MRIの有用性の検討 |
FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer |
| 科学的試験名略称/Scientific Title:Acronym |
肺癌に対するニボルマブ療法の効果予測におけるFDG-PET/MRIの有用性の検討 |
FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer |
| 試験実施地域/Region |
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| 目的/Objectives |
| 目的1/Narrative objectives1 |
ニボルマブはPD-1免疫チェックポイント阻害剤であり、非小細胞肺癌症例に有効な症例があり、長期に奏功する可能性がある。しかし、その効果の早期の予測はCTなどの通常の検査では困難である。
今回の試験の目的はFDG-PET/MRIの治療前後の変化が長期の奏功を予測可能であるかを検討することである。 |
Nivolumab, a programmed death 1 immune checkpoint inhibitor antibody, was active and durable in some patients with advanced non-small cell lung cancer. However, it is difficult to evaluate early response with conventional imaging (i.e. computed tomography).
The aim of this study is to clarify whether serial change of FDG-PET/MRI findings can predict long term tumor response of nivolumab monotherapy. |
| 目的2/Basic objectives2 |
その他/Others |
| 目的2 -その他詳細/Basic objectives -Others |
検査の診断的有用性を評価する |
To evaluate diagnostic relevancy of FDG-PET/MRI imaging. |
| 試験の性質1/Trial characteristics_1 |
探索的/Exploratory |
| 試験の性質2/Trial characteristics_2 |
実務的/Pragmatic |
| 試験のフェーズ/Developmental phase |
該当せず/Not applicable |
| 介入/Intervention |
| 群数/No. of arms |
1 |
| 介入の目的/Purpose of intervention |
診断/Diagnosis |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
ニボルマブ療法開始前、２，８，１６週後にFDG-PET/MRI検査を行う。 |
All patients undergo FDG-PET/MRI before and 2, 8 and 16 weeks after initiation of nivolumab therapy. |
| 介入2/Interventions/Control_2 |
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| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
・1レジメン以上の全身化学療法の治療歴がある非小細胞肺癌症例
・ECOG-PS 0-2の症例
・測定可能な病変がある症例
・文書による同意が得られた症例 |
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 |
| 除外基準/Key exclusion criteria |
・空腹時血糖が150mg/dL以上の症例
・妊娠中及び授乳中の症例
・取り外しのできないMRI非対応の体内金属を有する症例
・閉所恐怖症の症例
・胸部単純X線検査で明らかであるか症状を有する間質性肺炎症例
・膠原病・自己免疫性疾患を有する症例
・主治医もしくは研究担当者が不適当と判断した症例 |
1) Fasting serum glucose levels above 150 mg/dl
2) Pregnant woman
3) Patients with metalic device in their body
4) Patients with claustrophobia
5) Patients with obvious interstitial pneumonia or pulmonary fibrosis in the chest X-ray.
6) Patients with collagen vascular disease or autoimmune diseases
7) Other cases attending physician it is determined unsuitable for registration of the study |
| 目標参加者数/Target sample size |
25 |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
https://jitc.bmj.com/content/8/1/e000349 |
| 組み入れ参加者数/Number of participants that the trial has enrolled |
25 |
| 主な結果/Results |
NivolumabのORRは32％、DCRは64％であった。PD（9例）とnon-PD（16例）の間で治療前と2週後の変化率に有意差があったのはΔTLG とΔADC、ΔTLG+ΔADCであり、PDを予測する閾値をROC曲線を用いて15%、7%、16.5%に設定したところ、それぞれのnon-PD予測の正診率は76%、84%、92%であった。これらのcut off値で2群に症例を分けると、有意にPFSに差が見られた（ΔTLG 8.1 vs 1.9 mo, P=0.031; ΔADC 9.1 vs 1.9 mo, P=0.004; ΔTLG+ΔADC 9.0 vs 1.8 mo, P<0.001） |
Patients with non-progressive disease (non-PD) had significantly decreased TLG, increased ADCmean (that is, negative dADCmean), and lower dTLG+dADCmean than patients with PD. Among the parameters tested, receiver operating characteristic curve analysis revealed that a cut-off value of 16.5 for dTLG+dADCmean had the highest accuracy (92%) for distinguishing between non-PD and PD patients. |
| 主な結果入力日/Results date posted |
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| 結果掲載遅延/Results Delayed |
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| 結果遅延理由/Results Delay Reason |
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| 最初の試験結果の出版日/Date of the first journal publication of results |
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| 参加者背景/Baseline Characteristics |
Nivolumabの適応がある既治療非小細胞肺癌症例25症例を対象とした |
Twenty-five patients with previously treated NSCLC were enrolled prospectively and underwent 18F-FDG PET/MRI before and at 2 weeks after nivolumab therapy. |
| 参加者の流れ/Participant flow |
25症例の連続したNivolumabの適応のある症例を登録した |
We prospectively enrolled 25 consecutive patients treated at the University of Fukui Hospital from January 2016 to February 2018, and the protocol-defined final analysis was performed on August 31, 2018. |
| 有害事象/Adverse events |
なし |
None |
| 評価項目/Outcome measures |
ΔTLG とΔADC、ΔTLG+ΔADCであり、PDを予測する閾値をROC曲線を用いて15%、7%、16.5%に設定したところ、それぞれのnon-PD予測の正診率は76%、84%、92%であった。 |
A cut-off value of 16.5 for dTLG+dADCmean had the highest accuracy (92%) for distinguishing between non-PD and PD patients |
| 個別症例データ共有計画/Plan to share IPD |
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| 個別症例データ共有計画の詳細/IPD sharing Plan description |
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UMIN-CTR 臨床試験登録情報の閲覧