rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter - Tabular View

Tracking Information

First Received Date ^ICMJE

September 2, 2005

Last Updated Date

November 27, 2006

Start Date ^ICMJE

April 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00145366 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

Official Title ^ICMJE

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.

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:

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Benign Nontoxic and Toxic Goiter
Graves’ Disease

Intervention ^ICMJE

Drug: Recombinant human thyrotropin (Thyrogen)

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

110

Completion Date

July 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00145366

Responsible Party

Study ID Numbers ^ICMJE

008

Study Sponsor ^ICMJE

Odense University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Viveque Egsgaard Nielsen, MD

Odense University Hospital

Information Provided By

Odense University Hospital

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP