rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

Phase 2

Completed

• Conditions: Benign Nontoxic and Toxic Goiter; Graves' Disease

• Registration Number: NCT00145366
• Lead Sponsor: Odense University Hospital

Brief Summary

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:

1. Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine in nontoxic multinodular goiter.

2. 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.

3. Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume in healthy individuals? A randomized double-blind cross-over trial.

4. 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;

5. The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study Completion: 2005-07
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Status Verified: 2009-04
• Last Update Submitted: 2010-12-27
• Last Update Posted: 2010-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.

Trial Locations

Locations (1)

Department of Endocrinology, Odense University Hospital; 🇩🇰 Odense, Funen, Denmark