The study aims at clarifying (in a randomized, double-blinded design): 1. Whether stimulation with 0.1 mg rhTSH 24, 48 or 72 hours before induction of a 131I-tracer dosis increases the 131I uptake in patients with atoxic multinodular goitre and to study which time interval is the most optimal (Part I) 2. Whether patients suffering from atoxic multinodular goitre obtains a corresponding goitre reduction compared with a control group when stimulating with 0.1 mg rh TSH 24, 48 or 72 hours before 131I therapy and when reducing the thyroid radiation dose to 50 Gy (Part II) The two studies will be carried out successively on the same patient population. The 131I uptake will be carried out first followed by the I therapy itself. The patients are compared with a placebo-treated control group going through the same course of treatment, but the 131I dosis will be 100 Gy (standard treatment). After the 131I therapy, all patients are followed during one year with a regular ultrasound scan of the thyroid gland and control of the metabolic status. The patient satisfaction is monitored by the use of a visual-analogue-scale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
0.1 mg rhTSH administered intramuscularly
0.1 mg rhTSH administered intramuscularly
0.1 mg isotonic saline injected intramuscularly
Odense University Hospital
Odense, Denmark
An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo
Time frame: 24 and 96 hours after tracer administration
An inter-individual comparison of the thyroid 131I uptake between those who receive placebo and those who receive rhTSH
Time frame: 24 and 96 hours after tracer administration
An estimation of which time-interval, injecting rhTSH, that is more favourable before 131I therapy (24 hours, 48 hours or 72 hours)
Time frame: 24 and 96 hours after tracer administration
A comparison of the degree of goiter reduction when patients are prestimulated with rhTSH and receive a thyroid 131I dose of 50 Gy or when receiving conventional 131I, receiving a thyroid dose of 100 Gy
Time frame: 3, 6, 9 and 12 months after 131I therapy
A registration of adverse effects following rhTSH/placebo
Time frame: All adverse effects occuring within one year follow-up
Patient satisfaction (Visual Analogue Scale) before, 3 months post 131I therapy, and at the end of follow-up (1 year).
Time frame: baseline, 3 and 12 months after 131I therapy
Development of TPOab or TSHRab
Time frame: At 12 months follow-up
Thyroid function
Time frame: At 12 months follow up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.