rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

Graves' Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145366
• Other study ID #: 008
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2005
• Last updated: December 27, 2010
• Start date: April 2002
• Est. completion date: July 2005

Study information

• Verified date: April 2009
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Nontoxic and Toxic Goiter
• Goiter
• Graves Disease
• Graves' Disease

Intervention

Drug:
• Recombinant human thyrotropin (Thyrogen)

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Odense University Hospital	Odense	Funen

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Nielsen VE, Bonnema SJ, Boel-Jørgensen H, Grupe P, Hegedüs L. Stimulation with 0.3-mg recombinant human thyrotropin prior to iodine 131 therapy to improve the size reduction of benign nontoxic nodular goiter: a prospective randomized double-blind trial. A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.