rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

Study Overview
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Brief Summary
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The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter. It is an introduction of a novel principle, based on prospective, randomized double blind investigations. Attached to this, we investigate the acute effects of rhTSH on thyroid size (measured by ultrasonography), both in healthy individuals and in patients with nontoxic nodular goiter. Thus, the investigations are divided into 4 categories listed below: Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine in nontoxic multinodular goiter. Prospective randomized double blind study of the pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine on thyroid size and function in patients with a very large (>100 ml) nontoxic or toxic goiter. Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume in healthy individuals? A randomized double-blind cross-over trial. Does administration of 0.3 mg recombinant human TSH affect thyroid function and volume in healthy individuals and in patients with multinodular non-toxic goiter? A randomized double-blind cross-over trial. As a final note we investigate, in a pilot-study; The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.

Official Title
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Pretreatment With Recombinant Human Thyrotropin (rhTSH) for the Effect on Thyroid Size and Function, and for the Effect of Radioiodine Treatment in Patients With Nodular Goiter. Prospective, Randomized Double-blinded Trials.

Conditions
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Benign Nontoxic and Toxic Goiter, Graves' Disease

Intervention / Treatment
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* Drug: Recombinant human thyrotropin (Thyrogen)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers with an intact thyroid gland Patients with nontoxic/subtoxic nodular goiter confirmed by ultrasonography Patients with toxic nodular goiter Patients with Graves' disease Exclusion Criteria: Treatment with drugs that alter thyroid function or size (the last 3 months prior to inclusion) Prior 131I treatment Alcohol, medicine or drug abuse Pregnancy or lactation No safe contraception Participation in another clinical trial Allergic reaction towards rhTSH Fine needle biopsy without valid diagnostic criteria for benign disease Suspicion of malignancy, increased ionized serum calcium and/or serum calcitonin Incontinence Physically or psychic condition that hinders corporation Ischemic attack up till 3 months before inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Recombinant human thyrotropin (Thyrogen)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign nontoxic and toxic goiter, rhTSH, 131I, goiter reduction, 131I kinetic, thyroid size, patient satisfaction, adverse effects, BRT, Graves' disease