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rhTSH, Radioiodine Uptake and Goiter Reduction Following 131I Therapy in Patients With Benign Nontoxic Nodular Goiter

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ClinicalTrials.gov Identifier: NCT00275171
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):
Steen Bonnema, Odense University Hospital

Brief Summary:

The study aims at clarifying (in a randomized, double-blinded design):

  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.

Condition or disease Intervention/treatment Phase
Nodular Goiter Drug: Recombinant human thyrotropin (Thyrogen) Drug: recombinant human TSH Other: isotonic saline = placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of 0.1 mg Recombinant Human Thyrotropin (rhTSH) on Thyroid Radioiodine-uptake and the Degree of Goiter Reduction Following 131I-therapy, in Patients With Benign Non-toxic Nodular Goiter. A Randomized, Double-blind, Placebo-controlled Trial.
Study Start Date : February 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
Active Comparator: rhTSH
proceeded by 0.1 mg rhTSH
Drug: Recombinant human thyrotropin (Thyrogen)
0.1 mg rhTSH administered intramuscularly

Drug: recombinant human TSH
0.1 mg rhTSH administered intramuscularly

Placebo Comparator: Placebo
1 ml isotonic saline
Other: isotonic saline = placebo
0.1 mg isotonic saline injected intramuscularly

Primary Outcome Measures :
  1. An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo [ Time Frame: 24 and 96 hours after tracer administration ]
  2. An inter-individual comparison of the thyroid 131I uptake between those who receive placebo and those who receive rhTSH [ Time Frame: 24 and 96 hours after tracer administration ]
  3. An estimation of which time-interval, injecting rhTSH, that is more favourable before 131I therapy (24 hours, 48 hours or 72 hours) [ Time Frame: 24 and 96 hours after tracer administration ]
  4. A comparison of the degree of goiter reduction when patients are prestimulated with rhTSH and receive a thyroid 131I dose of 50 Gy or when receiving conventional 131I, receiving a thyroid dose of 100 Gy [ Time Frame: 3, 6, 9 and 12 months after 131I therapy ]

Secondary Outcome Measures :
  1. A registration of adverse effects following rhTSH/placebo [ Time Frame: All adverse effects occuring within one year follow-up ]
  2. Patient satisfaction (Visual Analogue Scale) before, 3 months post 131I therapy, and at the end of follow-up (1 year). [ Time Frame: baseline, 3 and 12 months after 131I therapy ]
  3. Development of TPOab or TSHRab [ Time Frame: At 12 months follow-up ]
  4. Thyroid function [ Time Frame: At 12 months follow up. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age over 18 years
  • Apart from benign non-toxic goiter no other serious illness
  • Signed proof of participation

Exclusion Criteria:

  • Treatment with Levothyroxine
  • 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

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): NCT00275171

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Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Steen Bonnema
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Principal Investigator: Steen J. Bonnema, MD Odense University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Steen Bonnema, Consultant, phd, DMsc, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00275171    
Other Study ID Numbers: 019
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013
Keywords provided by Steen Bonnema, Odense University Hospital:
Nontoxic nodular goiter
131I therapy
thyroid radioiodine uptake
optimal time-interval
reduced 131I activity
goiter reduction
Additional relevant MeSH terms:
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Goiter, Nodular
Thyroid Diseases
Endocrine System Diseases