rhTSH, Radioiodine Uptake and Goiter Reduction Following 131I Therapy in Patients With Benign Nontoxic Nodular Goiter
NCT ID: NCT00275171
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2006-02-28
2009-09-30
Brief Summary
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1. Whether stimulation with 0.1 mg rhTSH 24, 48 or 72 hours before induction of a 131I-tracer dosis increases the 131I uptake in patients with atoxic multinodular goitre and to study which time interval is the most optimal (Part I)
2. Whether patients suffering from atoxic multinodular goitre obtains a corresponding goitre reduction compared with a control group when stimulating with 0.1 mg rh TSH 24, 48 or 72 hours before 131I therapy and when reducing the thyroid radiation dose to 50 Gy (Part II)
The two studies will be carried out successively on the same patient population. The 131I uptake will be carried out first followed by the I therapy itself. The patients are compared with a placebo-treated control group going through the same course of treatment, but the 131I dosis will be 100 Gy (standard treatment). After the 131I therapy, all patients are followed during one year with a regular ultrasound scan of the thyroid gland and control of the metabolic status. The patient satisfaction is monitored by the use of a visual-analogue-scale.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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rhTSH
proceeded by 0.1 mg rhTSH
Recombinant human thyrotropin (Thyrogen)
0.1 mg rhTSH administered intramuscularly
recombinant human TSH
0.1 mg rhTSH administered intramuscularly
Placebo
1 ml isotonic saline
isotonic saline = placebo
0.1 mg isotonic saline injected intramuscularly
Interventions
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Recombinant human thyrotropin (Thyrogen)
0.1 mg rhTSH administered intramuscularly
recombinant human TSH
0.1 mg rhTSH administered intramuscularly
isotonic saline = placebo
0.1 mg isotonic saline injected intramuscularly
Eligibility Criteria
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Inclusion Criteria
* Apart from benign non-toxic goiter no other serious illness
* Signed proof of participation
Exclusion Criteria
* Former 131I-therapy
* A thyroid volume above 100 ml or a retro-clavicular component
* Unsafe contraception
* Pregnancy or breastfeeding
* Participation in another clinical trial
* Previous allergic reaction toward rhTSH
* Suspicion of malignancy in the thyroid gland either by clinical examination, laboratory findings (a raised serum calcitonin or ionized calcium)or by fine-needle aspiration biopsy
* Physically or mental condition making it impossible to participate
* Acute ischemic heart attach within the last 3 months
* Alcohol and/or drug addicts
18 Years
ALL
No
Sponsors
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Steen Bonnema
OTHER
Responsible Party
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Steen Bonnema
Consultant, phd, DMsc
Principal Investigators
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Steen J. Bonnema, MD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Countries
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References
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Huo Y, Xie J, Chen S, Wang H, Ma C. Recombinant human thyrotropin (rhTSH)-aided radioiodine treatment for non-toxic multinodular goitre. Cochrane Database Syst Rev. 2021 Dec 28;12(12):CD010622. doi: 10.1002/14651858.CD010622.pub2.
Fast S, Hegedus L, Grupe P, Nielsen VE, Bluhme C, Bastholt L, Bonnema SJ. Recombinant human thyrotropin-stimulated radioiodine therapy of nodular goiter allows major reduction of the radiation burden with retained efficacy. J Clin Endocrinol Metab. 2010 Aug;95(8):3719-25. doi: 10.1210/jc.2010-0634. Epub 2010 Jun 2.
Other Identifiers
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019
Identifier Type: -
Identifier Source: org_study_id