rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

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.

Timeline

Start

2002-04

Primary completion

—

Completion

2005-07

Outcome

Met primary endpoint

paper relative goiter reduction was 46.1% +/- 4.0% in the placebo group and 62.1% +/- 3.0% in the thyrotropin group (P = .002 between groups). PMID 16864757 ↗

paper Stimulation with recombinant human thyrotropin prior to (131)I therapy improves thyroid size reduction by 35% PMID 16864757 ↗

Publications

• Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Recombinant human thyrotropin	Unknown	0.3 mg	—
Subject	Recombinant human thyrotropin	Unknown	0.9 mg	—

Indications