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

NCT00275171 | Completed Phase 2 DMC

• 1 other identifier: 019
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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)

Conditions

Nodular Goiter

Keywords

Nontoxic nodular goiter; 131I therapy; thyroid radioiodine uptake; optimal time-interval; reduced 131I activity; goiter reduction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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.

Study Arms (2)

rhTSH

ACTIVE COMPARATOR

proceeded by 0.1 mg rhTSH

Drug: Recombinant human thyrotropin (Thyrogen); Drug: recombinant human TSH

Placebo

PLACEBO COMPARATOR

1 ml isotonic saline

Other: isotonic saline = placebo

Interventions

Recombinant human thyrotropin (Thyrogen) DRUG

0.1 mg rhTSH administered intramuscularly

rhTSH

recombinant human TSH DRUG

0.1 mg rhTSH administered intramuscularly

rhTSH

isotonic saline = placebo OTHER

0.1 mg isotonic saline injected intramuscularly

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Apart from benign non-toxic goiter no other serious illness
• Signed proof of participation

You may not qualify if:

• 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

Sponsors & Collaborators

• Steen Bonnema: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (2)

• Huo Y, Xie J, Chen S, Wang H, Ma C. Recombinant human thyrotropin (rhTSH)-aided radioiodine treatment for non-toxic multinodular goitre. Cochrane Database Syst Rev. 2021 Dec 28;12(12):CD010622. doi: 10.1002/14651858.CD010622.pub2.

  PMID: 34961921 DERIVED

• Fast S, Hegedus 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. doi: 10.1210/jc.2010-0634. Epub 2010 Jun 2.

  PMID: 20519346 DERIVED

MeSH Terms

Conditions

Goiter, Nodular

Interventions

Thyrotropin Alfa

Condition Hierarchy (Ancestors)

Goiter; Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyrotropin; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Steen J. Bonnema, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant, phd, DMsc

Study Record Dates

• First Submitted: January 9, 2006
• First Posted: January 11, 2006
• Study Start: February 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

DK (1)