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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00275171
Other study ID # 019
Secondary ID
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


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
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