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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

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Please use this identifier to cite or link to this item:http://hdl.handle.net/2115/72047

Title: 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
Authors: Takeuchi, Satoshi Browse this author
Shiga, Tohru Browse this author →KAKEN DB
Hirata, Kenji Browse this author →KAKEN DB
Taguchi, Jun Browse this author
Magota, Keiichi Browse this author →KAKEN DB
Ariga, Shin Browse this author
Gouda, Tomohiro Browse this author
Ohhara, Yoshihito Browse this author
Homma, Rio Browse this author
Shimizu, Yasushi Browse this author →KAKEN DB
Kinoshita, Ichiro Browse this author →KAKEN DB
Tsuji, Yasushi Browse this author
Homma, Akihiro Browse this author →KAKEN DB
Iijima, Hiroaki Browse this author
Tamaki, Nagara Browse this author →KAKEN DB
Dosaka-Akita, Hirotoshi Browse this author →KAKEN DB
Issue Date: Nov-2018
Publisher: BMJ Publishing Group
Journal Title: BMJ Open
Volume: 8
Issue: 8
Start Page: e021001
Publisher DOI: 10.1136/bmjopen-2017-021001
Abstract: 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.
Rights: http://creativecommons.org/licenses/by-nc/4.0/
Type: article
URI: http://hdl.handle.net/2115/72047
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 竹内 啓

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