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; 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

Title	en 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
Creator	en Takeuchi, Satoshi en Shiga, Tohru NRID 1000080374495 en Hirata, Kenji NRID 1000030431365 en Taguchi, Jun en Magota, Keiichi NRID 1000020636419 en Ariga, Shin en Gouda, Tomohiro en Ohhara, Yoshihito en Homma, Rio en Shimizu, Yasushi NRID 1000010374513 en Kinoshita, Ichiro NRID 1000040343008 en Tsuji, Yasushi en Homma, Akihiro NRID 1000030312359 en Iijima, Hiroaki en Tamaki, Nagara NRID 1000030171888 en Dosaka-Akita, Hirotoshi NRID 1000070222528
Accessrights	open access
Rights	http://creativecommons.org/licenses/by-nc/4.0/ en Creative Commons Attribution-NonCommercial 4.0 International
Subject	NDC 490
Description	Abstract en 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.
Publisher	en BMJ Publishing Group
Date	Issued2018-11
Language	eng
Resource Type	journal article
Version Type	VoR
Identifier	HDL http://hdl.handle.net/2115/72047
Relation	isIdenticalTo DOI https://doi.org/10.1136/bmjopen-2017-021001
Journal	PISSN 2044-6055 en BMJ Open Volume Number8 Issue Number8 Page Starte021001
File	fulltext e021001.full.pdf 426.3 KB (application/pdf) Issued2018-11
Oaidate	2023-07-26