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

Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nodular Goiter

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

Phase: Phase 2

Status: Completed

Sponsored by: Steen Bonnema

Official(s) and/or principal investigator(s):
Steen J. Bonnema, MD, Principal Investigator, Affiliation: Odense University Hospital

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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 outcome:

A registration of adverse effects following rhTSH/placebo

Patient satisfaction (Visual Analogue Scale) before, 3 months post 131I therapy, and at the end of follow-up (1 year).

Development of TPOab or TSHRab

Thyroid function

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Odense University Hospital, Odense 5000, Denmark
Additional Information

Starting date: February 2006
Last updated: December 3, 2013

Page last updated: August 23, 2015

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