Nodular Goiter
Conditions
Keywords
Nontoxic nodular goiter, 131I therapy, thyroid radioiodine uptake, optimal time-interval, reduced 131I activity, goiter reduction
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 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.
Interventions
0.1 mg rhTSH administered intramuscularly
DRUGrecombinant human TSH
0.1 mg rhTSH administered intramuscularly
OTHERisotonic saline = placebo
0.1 mg isotonic saline injected intramuscularly
Sponsors
Steen Bonnema
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years * Apart from benign non-toxic goiter no other serious illness * Signed proof of participation
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 3, 6, 9 and 12 months after 131I therapy |
| An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo | 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 | 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) | 24 and 96 hours after tracer administration |
Secondary
| Measure | Time frame |
|---|---|
| A registration of adverse effects following rhTSH/placebo | 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). | baseline, 3 and 12 months after 131I therapy |
| Development of TPOab or TSHRab | At 12 months follow-up |
| Thyroid function | At 12 months follow up. |
Countries
Denmark
Outcome results
None listed