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Benign Tumor |
Benign Tumors; Cancer, Benign; Tumors, Benign |
Clinical Trial: rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter.
This study is no longer recruiting patients.
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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:
- 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.
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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.
| Condition | Intervention | Phase |
|---|---|---|
| Benign nontoxic and toxic goiter Graves’ disease | Drug: Recombinant human thyrotropin (Thyrogen) | Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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.
Expected Total Enrollment: 110
Study start: April 2002; Study completion: December 2005
Last follow-up: July 2005; Data entry closure: July 2005
Eligibility
Accepts 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
Location Information
Denmark, Funen
Department of Endocrinology, Odense University Hospital, Odense, Funen, 5000, Denmark
Viveque Egsgaard Nielsen, MD, Principal Investigator, Odense University Hospital
More Information
Last Updated: September 2, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00145366
Health Authority: Denmark: National Board of Health
ClinicalTrials.gov processed this record on 2005-09-13
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