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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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Oncology
Protocol
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
  1. Satoshi Takeuchi1,
  2. Tohru Shiga2,
  3. Kenji Hirata2,
  4. Jun Taguchi1,
  5. Keiichi Magota3,
  6. Shin Ariga1,
  7. Tomohiro Gouda1,
  8. Yoshihito Ohhara1,
  9. Rio Homma1,
  10. Yasushi Shimizu1,
  11. Ichiro Kinoshita1,
  12. Yasushi Tsuji4,
  13. Akihiro Homma5,
  14. Hiroaki Iijima6,
  15. Nagara Tamaki2,
  16. Hirotoshi Dosaka-Akita1
  1. 1 Department of Medical Oncology, Hokkaido University Graduate School of Medicine, Sapporo, Japan
  2. 2 Department of Nuclear Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan
  3. 3 Department of Radiology, Hokkaido University Hospital, Sapporo, Hokkaido, Japan
  4. 4 Department of of Medical Oncology, Tonan Hospital, Sapporo, Hokkaido, Japan
  5. 5 Department of Otolaryngology-Head and Neck Surgery, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan
  6. 6 Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, Japan
  1. Correspondence to Dr Satoshi Takeuchi; stakeuch{at}med.hokudai.ac.jp

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.

  • chemotherapy
  • thyroid disease
  • nuclear medicine

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2017-021001

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    Footnotes

    • Contributors ST: is the project leader. ST, KH and HI: wrote the manuscript. ST, TS, KH, JT, SA , TG, YO, RH, YS, IK, YT, AH, NT and HD-A: are participating in patient recruitment and data collection. TS, KH and KM: are performing the FDG PET/CT procedure. HI: responsible for calculating the sample size and performing data analysis. All authors contributed to devising the study concept; read and approved the final manuscript.

    • Funding This trial was supported by the Pfizer Health Research Foundation (grant number: 28-22).

    • Competing interests None declared.

    • Ethics approval Approved by the institutional review board of the participating institution.

    • Provenance and peer review Not commissioned; externally peer reviewed.