rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

NCT ID: NCT00145366

Last Updated: 2010-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2005-07-31

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.

Conditions

Benign Nontoxic and Toxic Goiter; Graves' Disease

Keywords

Benign nontoxic and toxic goiter; rhTSH; 131I; goiter reduction; 131I kinetic; thyroid size; patient satisfaction; adverse effects; BRT; Graves' disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Recombinant human thyrotropin (Thyrogen)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Viveque Egsgaard Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Department of Endocrinology, Odense University Hospital

Odense, Funen, Denmark

Countries

Denmark

References

Nielsen VE, Bonnema SJ, Boel-Jorgensen H, Grupe P, Hegedus 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. Arch Intern Med. 2006 Jul 24;166(14):1476-82. doi: 10.1001/archinte.166.14.1476.

Reference Type: RESULT

PMID: 16864757 (View on PubMed)

Other Identifiers

008

Identifier Type: -

Identifier Source: org_study_id