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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 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.


Detailed Summary:
Sponsor: Steen Bonnema

Current Primary Outcome:

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]


Original Primary Outcome:

  • • 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


Current Secondary Outcome:

  • A registration of adverse effects following rhTSH/placebo [ Time Frame: 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). [ Time Frame: baseline, 3 and 12 months after 131I therapy ]
  • Development of TPOab or TSHRab [ Time Frame: At 12 months follow-up ]
  • Thyroid function [ Time Frame: At 12 months follow up. ]


Original Secondary Outcome:

  • • A registration of adverse effects following rhTSH/placebo
  • • Patient satisfaction (Visual Analouge Scale) before, 3 months post 131I therapy, and at the end of follow-up (1 year).
  • • Development of TPOab or TSHRab
  • • Thyroid function


Information By: Odense University Hospital

Dates:
Date Received: January 9, 2006
Date Started: February 2006
Date Completion:
Last Updated: December 3, 2013
Last Verified: December 2013