RADTHYR: an open-label, single-arm, prospective multicenter phase II trial of Radium-223 for the treatment of bone metastases from radioactive iodine refractory differentiated thyroid cancer.

ABSTRACT:

Purpose

This is the first prospective trial evaluating the efficacy of alpha emitter Radium-223 in patients with bone metastases from radioactive iodine (RAI) refractory (RAIR) differentiated thyroid cancer.

Methods

RADTHYR is a multicenter, single-arm prospective Simon two-stage phase II trial (NCT02390934). The primary objective was to establish the efficacy of three administrations of 55 kBq/kg of Radium-223 by ¹⁸F-FDG PET/CT according to PERCIST criteria. Secondary objectives were to establish the efficacy of six administrations of Radium-223 by ¹⁸F-FDG PET/CT, ^99mTc-HMDP bone scan and ¹⁸FNa PET/CT, clinical benefits, changes in serum bone markers, thyroglobulin levels, and safety.

Results

Ten patients were enrolled betw

SUBMITTER: Deandreis D 

PROVIDER: S-EPMC8426251 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature