ClinicalTrials.gov
ClinicalTrials.gov Menu

rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00145366
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : December 28, 2010
Sponsor:
Information provided by:
Odense University Hospital

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.

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 110 participants
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 : April 2002
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Calcitonin
U.S. FDA Resources




Primary Outcome Measures :
  1. Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
ClinicalTrials.gov Identifier: NCT00145366     History of Changes
Other Study ID Numbers: 008
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: December 28, 2010
Last Verified: April 2009

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:
Graves Disease
Goiter
Exophthalmos
Orbital Diseases
Eye Diseases
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs