| 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)
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