Clinical trial NCT00145366: rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Nontoxic and Toxic Goiter
Graves' Disease
Keywords: Benign nontoxic and toxic goiter
rhTSH
131I
goiter reduction
131I kinetic
thyroid size
patient satisfaction
adverse effects
BRT
Graves' disease
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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:

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.


Eligibility 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

Primary outcomes:
measure: Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology, Odense University Hospital
state: Funen
Study officials:
affiliation: Odense University Hospital
name: Viveque Egsgaard Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.