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rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00145366
First received: September 2, 2005
Last updated: December 27, 2010
Last verified: April 2009
  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:

  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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
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:
ClinicalTrials.gov Identifier: NCT00145366     History of Changes
Other Study ID Numbers: 008
Study First Received: September 2, 2005
Last Updated: December 27, 2010
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

Additional relevant MeSH terms:
Goiter
Graves Disease
Autoimmune Diseases
Endocrine System Diseases
Exophthalmos
Eye Diseases
Hyperthyroidism
Immune System Diseases
Orbital Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on November 25, 2014