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

Nodular Goiter Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275171
• Other study ID #: 019
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2006
• Last updated: December 3, 2013
• Start date: February 2006
• Est. completion date: September 2009

Study information

• Verified date: December 2013
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Goiter
• Goiter, Nodular
• Nodular Goiter

Intervention

Drug:
• Recombinant human thyrotropin (Thyrogen)
0.1 mg rhTSH administered intramuscularly
• recombinant human TSH
0.1 mg rhTSH administered intramuscularly

Other:
• isotonic saline = placebo
0.1 mg isotonic saline injected intramuscularly

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Steen Bonnema

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo		24 and 96 hours after tracer administration	No
Primary	An inter-individual comparison of the thyroid 131I uptake between those who receive placebo and those who receive rhTSH		24 and 96 hours after tracer administration	No
Primary	An estimation of which time-interval, injecting rhTSH, that is more favourable before 131I therapy (24 hours, 48 hours or 72 hours)		24 and 96 hours after tracer administration	No
Primary	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		3, 6, 9 and 12 months after 131I therapy	No
Secondary	A registration of adverse effects following rhTSH/placebo		All adverse effects occuring within one year follow-up	Yes
Secondary	Patient satisfaction (Visual Analogue Scale) before, 3 months post 131I therapy, and at the end of follow-up (1 year).		baseline, 3 and 12 months after 131I therapy	No
Secondary	Development of TPOab or TSHRab		At 12 months follow-up	Yes
Secondary	Thyroid function		At 12 months follow up.	No