Nodular Goiter Clinical Trial
Official title:
The Effect of 0.1 mg Recombinant Human Thyrotropin (rhTSH) on Thyroid Radioiodine-uptake and the Degree of Goiter Reduction Following 131I-therapy, in Patients With Benign Non-toxic Nodular Goiter. A Randomized, Double-blind, Placebo-controlled Trial.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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