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

Sponsored by:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00145366

Purpose

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.

Condition	Intervention	Phase
Benign Nontoxic and Toxic Goiter Graves’ Disease	Drug: Recombinant human thyrotropin (Thyrogen)	Phase II

MedlinePlus related topics: Ultrasound

Drug Information available for: Thyroid Thyrotropin alfa Thyrotropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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.

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

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

Estimated Enrollment:	110
Study Start Date:	April 2002
Estimated Study Completion Date:	July 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145366

Locations

Denmark, Funen
Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000

Sponsors and Collaborators

Odense University Hospital

Investigators

Principal Investigator:

Viveque Egsgaard Nielsen, MD

Odense University Hospital

More Information

Publications of 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.

Study ID Numbers:	008
Study First Received:	September 2, 2005
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00145366
Health Authority:	Denmark: National Board of Health

Keywords provided by Odense University Hospital:

Benign nontoxic and toxic goiter
rhTSH
131I
goiter reduction
131I kinetic

thyroid size
patient satisfaction
adverse effects
BRT
Graves’ disease

Study placed in the following topic categories:

Goiter
Autoimmune Diseases
Eye Diseases
Graves Disease
Endocrine System Diseases
Endocrinopathy

Orbital Diseases
Goiter, Nodular
Graves' disease
Hyperthyroidism
Thyroid Diseases

Additional relevant MeSH terms:

Immune System Diseases
Exophthalmos

ClinicalTrials.gov processed this record on January 16, 2009