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

Sponsor:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00275171

Purpose

The study aims at clarifying (in a randomized, double-blinded design):

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)
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
Nodular Goiter	Drug: Recombinant human thyrotropin (Thyrogen)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

Drug Information available for: Thyroid Thyrotropin

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	90
Study Start Date:	February 2006
Estimated Study Completion Date:	June 2009

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275171

Contacts

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

Locations

Denmark
Odense University Hospital	Recruiting
Odense, Denmark, 5000
Contact: Steen J. Bonnema, MD +45 6541 3437 steen.bonnema@ouh.fyns-amt.dk
Contact: Soren Fast, MD +45 6541 3437 doctorfast@hotmail.com
Principal Investigator: Steen J. Bonnema, MD

Sponsors and Collaborators

Odense University Hospital

Investigators

Principal Investigator:

Steen J. Bonnema, MD

Odense University Hospital

More Information

No publications provided

Study ID Numbers:	019
Study First Received:	January 9, 2006
Last Updated:	March 26, 2007
ClinicalTrials.gov Identifier:	NCT00275171 History of Changes
Health Authority:	Denmark: National Board of Health

Keywords provided by Odense University Hospital:

Nontoxic nodular goiter
131I therapy
thyroid radioiodine uptake

optimal time-interval
reduced 131I activity
goiter reduction

Additional relevant MeSH terms:

Goiter
Endocrine System Diseases
Goiter, Nodular
Thyroid Diseases

ClinicalTrials.gov processed this record on February 08, 2010