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rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

Primary Purpose

Benign Nontoxic and Toxic Goiter, Graves' Disease

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Recombinant human thyrotropin (Thyrogen)
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Nontoxic and Toxic Goiter focused on measuring Benign nontoxic and toxic goiter, rhTSH, 131I, goiter reduction, 131I kinetic, thyroid size, patient satisfaction, adverse effects, BRT, Graves' disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Endocrinology, Odense University Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 2, 2005
Last Updated
December 27, 2010
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00145366
Brief Title
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

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Odense University Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
110 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Recombinant human thyrotropin (Thyrogen)
Primary Outcome Measure Information:
Title
Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viveque Egsgaard Nielsen, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, Odense University Hospital
City
Odense
State/Province
Funen
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
16864757
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.
Results Reference
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rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

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