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) Drug: recombinant human TSH Other: isotonic saline = placebo	Phase II

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

MedlinePlus related topics: Thyroid Diseases

Drug Information available for: Thyrotropin alfa 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 [ Time Frame: 24 and 96 hours after tracer administration ] [ Designated as safety issue: No ]
An inter-individual comparison of the thyroid 131I uptake between those who receive placebo and those who receive rhTSH [ Time Frame: 24 and 96 hours after tracer administration ] [ Designated as safety issue: No ]
An estimation of which time-interval, injecting rhTSH, that is more favourable before 131I therapy (24 hours, 48 hours or 72 hours) [ Time Frame: 24 and 96 hours after tracer administration ] [ Designated as safety issue: No ]
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 [ Time Frame: 3, 6, 9 and 12 months after 131I therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A registration of adverse effects following rhTSH/placebo [ Time Frame: All adverse effects occuring within one year follow-up ] [ Designated as safety issue: Yes ]
Patient satisfaction (Visual Analogue Scale) before, 3 months post 131I therapy, and at the end of follow-up (1 year). [ Time Frame: baseline, 3 and 12 months after 131I therapy ] [ Designated as safety issue: No ]
Development of TPOab or TSHRab [ Time Frame: At 12 months follow-up ] [ Designated as safety issue: Yes ]
Thyroid function [ Time Frame: At 12 months follow up. ] [ Designated as safety issue: No ]

Enrollment:	90
Study Start Date:	February 2006
Study Completion Date:	September 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: rhTSH proceeded by 0.1 mg rhTSH	Drug: Recombinant human thyrotropin (Thyrogen) 0.1 mg rhTSH administered intramuscularly Drug: recombinant human TSH 0.1 mg rhTSH administered intramuscularly
Placebo Comparator: Placebo 1 ml isotonic saline	Other: isotonic saline = placebo 0.1 mg isotonic saline injected intramuscularly

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

Locations

Denmark
Odense University Hospital
Odense, Denmark, 5000

Sponsors and Collaborators

Odense University Hospital

Investigators

Principal Investigator:

Steen J. Bonnema, MD

Odense University Hospital

More Information

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fast S, Hegedüs L, Grupe P, Nielsen VE, Bluhme C, Bastholt L, Bonnema SJ. Recombinant human thyrotropin-stimulated radioiodine therapy of nodular goiter allows major reduction of the radiation burden with retained efficacy. J Clin Endocrinol Metab. 2010 Aug;95(8):3719-25. Epub 2010 Jun 2.

Responsible Party:	Steen J. Bonnema, MD, Odense university hospital
ClinicalTrials.gov Identifier:	NCT00275171 History of Changes
Other Study ID Numbers:	019
Study First Received:	January 9, 2006
Last Updated:	December 27, 2010
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
Goiter, Nodular
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012