The study is to demonstrate non-inferior thyroid remnant first ablation success of Thyrogen and 131I compared to thyroid hormone withdrawal (THW) and 131I in patients with T4 tumour based on historical diagnostic whole body scan (DxWBS) records.
Study Type
OBSERVATIONAL
Enrollment
144
Hanover University School of Medicine
Hanover, Germany
Klinikum Großhadern
München, Germany
Policlinico S.Orsola-Malpighi
Bologna, Italy
Instituto Oncologico Veneto
Padova, Italy
First ablation success rate by Diagnostic Whole Body Scan (DxWBS)
Time frame: at least 6 months after administration of first ablation activity of 131I
First ablation success rate based on stimulated Thyroglobulin (Tg) levels
Time frame: at least 6 months after administration of first ablation activity of 131I
First ablation success rate based on historical records
Time frame: at least 6 months after administration of first ablation activity of 131I
Number of adverse events of Thyrogen and 131I arm and THW and 131I arm
Exploratory safety assessment in patients with T4 tumour for first ablation of thyroid remnants based on historical records.
Time frame: Within 30 days of treatment.
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Istituti Fisioterapici Ospitalieri (IFO)
Rome, Italy
Portuguese Institute of Oncology
Coimbra, Portugal
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Universitario Dr Peset
Valencia, Spain