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	Intervention	Phase
Benign Nontoxic Nodular Goitre	Drug: Recombinant human thyrotropin (Thyrogen)	Phase II

Further study details as provided by Odense University Hospital:

Primary Outcomes: • An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo; • An inter-individual comparison of the thyroid 131I uptake between those who receive placebo and those who receive rhTSH; • An estimation of which time-interval, injecting rhTSH, that is more favourable before 131I therapy (24 hours, 48 hours or 72 hours); • 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
Secondary Outcomes: • A registration of adverse effects following rhTSH/placebo; • Patient satisfaction (Visual Analouge Scale) before, 3 months post 131I therapy, and at the end of follow-up (1 year).; • Development of TPOab or TSHRab; • Thyroid function
Expected Total Enrollment:  90

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Treatment with Levothyroxine
• Former 131I-therapy
• A thyroid volume above 100 ml or a retroclavicular 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 Calcitonine 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00275171

Steen J. Bonnema, MD      +45 6541 3437    steen.bonnema@ouh.fyns-amt.dk
Viveque E. Nielsen, MD      +45 6541 1696    viveque.egsgaard@ouh.fyns-amt.dk

Denmark
      Odense University Hospital, Odense,  5000,  Denmark

Study chairs or principal investigators

Steen J. Bonnema, MD,  Principal Investigator,  Odense University Hospital   

Study ID Numbers:  19
Last Updated:  January 10, 2006
Record first received:  January 9, 2006
ClinicalTrials.gov Identifier:  NCT00275171
Health Authority: Denmark: National Board of Health
ClinicalTrials.gov processed this record on 2006-01-17