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

Sponsor

Steen Bonnema (Other)

Overall Status

Completed

CT.gov ID

NCT00275171

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Nodular Goiter	Drug: Recombinant human thyrotropin (Thyrogen) Drug: recombinant human TSH Other: isotonic saline = placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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.

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo [24 and 96 hours after tracer administration]
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]
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]
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]

Secondary Outcome Measures

A registration of adverse effects following rhTSH/placebo [All adverse effects occuring within one year follow-up]
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]
Development of TPOab or TSHRab [At 12 months follow-up]
Thyroid function [At 12 months follow up.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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