Early prediction of lenvatinib treatment efficacy by using 18F-FDG PET/CT in patients with unresectable or advanced thyroid carcinoma that is refractory to radioiodine treatment : a protocol for a non-randomized single-arm multicenter observational study

Takeuchi, Satoshi; Shiga, Tohru; Hirata, Kenji et al.

BMJ Open, 2018, 8(8), e021001

Permalink : https://hdl.handle.net/2115/72047

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アクセス権
open access
URI
https://hdl.handle.net/2115/72047
タイトル
Early prediction of lenvatinib treatment efficacy by using 18F-FDG PET/CT in patients with unresectable or advanced thyroid carcinoma that is refractory to radioiodine treatment : a protocol for a non-randomized single-arm multicenter observational study
著者
Takeuchi, Satoshi ; Shiga, Tohru ; Hirata, Kenji ; Taguchi, Jun ; Magota, Keiichi ; Ariga, Shin ; Gouda, Tomohiro ; Ohhara, Yoshihito ; Homma, Rio ; Shimizu, Yasushi ; Kinoshita, Ichiro ; Tsuji, Yasushi ; Homma, Akihiro ; Iijima, Hiroaki ; Tamaki, Nagara ; Dosaka-Akita, Hirotoshi
著者名
Takeuchi, Satoshi
e-Rad_Researcher
80374495
著者名
Shiga, Tohru
e-Rad_Researcher
30431365
著者名
Hirata, Kenji
著者名
Taguchi, Jun
e-Rad_Researcher
20636419
著者名
Magota, Keiichi
著者名
Ariga, Shin
著者名
Gouda, Tomohiro
著者名
Ohhara, Yoshihito
著者名
Homma, Rio
e-Rad_Researcher
10374513
著者名
Shimizu, Yasushi
e-Rad_Researcher
40343008
著者名
Kinoshita, Ichiro
著者名
Tsuji, Yasushi
e-Rad_Researcher
30312359
著者名
Homma, Akihiro
著者名
Iijima, Hiroaki
e-Rad_Researcher
30171888
著者名
Tamaki, Nagara
e-Rad_Researcher
70222528
著者名
Dosaka-Akita, Hirotoshi
言語
英語
発行日
2018-11
出版者
BMJ Publishing Group
収録物名
BMJ Open
巻(号)
8(8)
ページ
e021001
抄録
Introduction: Lenvatinib, an oral molecular targeted drug, is used to treat patients with unresectable or advanced thyroid carcinoma that is refractory to radioiodine treatment. Effective methods for evaluating molecular targeted drugs are a critical unmet need owing to their expensive costs and unique adverse events. The aim of this study is to determine whether 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT at 1 week after commencing lenvatinib can predict treatment outcomes. Design and methods: This study is planned as a non-randomised single-arm multicentre study; patients with pathologically confirmed differentiated thyroid carcinoma (DTC) with lesions that are refractory to radioiodine treatment are eligible. The main exclusion criteria are medullary or anaplastic carcinoma, prior treatment with chemotherapy, poor general condition and thromboembolism-requiring treatment. Patients to be included in the study will be treated with lenvatinib and undergo FDG-PET/CT examination twice: before and 1 week after the initiation of treatment. Contrast-enhanced CT, the gold standard for evaluation, will be performed at least 4 weeks after the initiation of treatment. The primary objective is to evaluate the ability of the lesion maximum standard uptake value for FDG PET/CT performed 1 week after the initiation of treatment to predict outcomes compared with the response evaluation obtained via contrast-enhanced CT performed at least 4 weeks after the initiation of treatment. Ethics and dissemination: This study is conducted in accordance with the Declaration of Helsinki and has received ethical approval from the institutional review board of the Hokkaido University Hospital (approval number: 015-402). The results of this study will be disseminated through a presentation at a conference and the publication of the data in a peer-reviewed journal. The study will be implemented and reported in line with the SPIRIT statement. Trial registration number: UMIN000022592.
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学術雑誌論文
出版タイプ
Version of Record
権利情報
Creative Commons Attribution-NonCommercial 4.0 International
PISSN
2044-6055
関連情報 (isIdenticalTo)
出版社版DOI
https://doi.org/10.1136/bmjopen-2017-021001