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NCT Number: NCT00275171

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

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.

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Key information

Conditions

Nodular Goiter Endocrine System Diseases Goiter Goiter, Nodular Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant human thyrotropin (Thyrogen)

Drug

0.1 mg rhTSH administered intramuscularly

recombinant human TSH

Drug

0.1 mg rhTSH administered intramuscularly

isotonic saline = placebo

Other

0.1 mg isotonic saline injected intramuscularly

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Steen Bonnema

Other

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 11, 2006
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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