rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00145366

Collaborator

(none)

110

Enrollment

Location

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Nontoxic and Toxic Goiter Graves' Disease	Drug: Recombinant human thyrotropin (Thyrogen)	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

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.

Study Start Date :

Apr 1, 2002

Actual Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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