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

Steen Bonnema

Status and phase: Completed; Phase 2

Conditions: Nodular Goiter

Treatments: Drug: Recombinant human thyrotropin (Thyrogen); Drug: recombinant human TSH; Other: isotonic saline = placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00275171

019

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

rhTSH

Active Comparator group

Description:

proceeded by 0.1 mg rhTSH

Treatment:

Drug: recombinant human TSH

Drug: Recombinant human thyrotropin (Thyrogen)

Placebo

Placebo Comparator group

Description:

1 ml isotonic saline

Treatment:

Other: isotonic saline = placebo