Status:
COMPLETED
rhTSH, Radioiodine Uptake and Goiter Reduction Following 131I Therapy in Patients With Benign Nontoxic Nodular Goiter
Lead Sponsor:
Steen Bonnema
Conditions:
Nodular Goiter
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Age over 18 years
- Apart from benign non-toxic goiter no other serious illness
- Signed proof of participation
Exclusion
- Treatment with Levothyroxine
- Former 131I-therapy
- A thyroid volume above 100 ml or a retro-clavicular component
- Unsafe contraception
- Pregnancy or breastfeeding
- Participation in another clinical trial
- Previous allergic reaction toward rhTSH
- Suspicion of malignancy in the thyroid gland either by clinical examination, laboratory findings (a raised serum calcitonin or ionized calcium)or by fine-needle aspiration biopsy
- Physically or mental condition making it impossible to participate
- Acute ischemic heart attach within the last 3 months
- Alcohol and/or drug addicts
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00275171
Start Date
February 1 2006
End Date
September 1 2009
Last Update
December 4 2013
Active Locations (1)
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1
Odense University Hospital
Odense, Denmark, 5000