rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter
Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Nontoxic and Toxic Goiter; Graves' Disease
Intervention: Recombinant human thyrotropin (Thyrogen) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Odense University Hospital Official(s) and/or principal investigator(s):
Viveque Egsgaard Nielsen, MD, Principal Investigator, Affiliation: Odense University Hospital
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Department of Endocrinology, Odense University Hospital, Odense, Funen 5000, Denmark
Additional Information
Starting date: April 2002
Last updated: December 27, 2010
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