NCT00145366

Brief Summary

The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter. It is an introduction of a novel principle, based on prospective, randomized double blind investigations. Attached to this, we investigate the acute effects of rhTSH on thyroid size (measured by ultrasonography), both in healthy individuals and in patients with nontoxic nodular goiter. Thus, the investigations are divided into 4 categories listed below:

  1. 1.Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine in nontoxic multinodular goiter.
  2. 2.Prospective randomized double blind study of the pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine on thyroid size and function in patients with a very large (\>100 ml) nontoxic or toxic goiter.
  3. 3.Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume in healthy individuals? A randomized double-blind cross-over trial.
  4. 4.Does administration of 0.3 mg recombinant human TSH affect thyroid function and volume in healthy individuals and in patients with multinodular non-toxic goiter? A randomized double-blind cross-over trial.
  5. 5.The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

December 28, 2010

Status Verified

April 1, 2009

First QC Date

September 2, 2005

Last Update Submit

December 27, 2010

Conditions

Benign Nontoxic and Toxic GoiterGraves' Disease

Keywords

Benign nontoxic and toxic goiterrhTSH131Igoiter reduction131I kineticthyroid sizepatient satisfactionadverse effectsBRTGraves' disease

Outcome Measures

Primary Outcomes (1)

  • Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.

Interventions

Recombinant human thyrotropin (Thyrogen)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers with an intact thyroid gland
  • Patients with nontoxic/subtoxic nodular goiter confirmed by ultrasonography
  • Patients with toxic nodular goiter
  • Patients with Graves' disease

You may not qualify if:

  • Prior 131I treatment
  • Alcohol, medicine or drug abuse
  • Pregnancy or lactation
  • No safe contraception
  • Participation in another clinical trial
  • Allergic reaction towards rhTSH
  • Fine needle biopsy without valid diagnostic criteria for benign disease
  • Suspicion of malignancy, increased ionized serum calcium and/or serum calcitonin
  • Incontinence
  • Physically or psychic condition that hinders corporation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, Funen, 5000, Denmark

Location

Related Publications (1)

  • Nielsen VE, Bonnema SJ, Boel-Jorgensen H, Grupe P, Hegedus L. Stimulation with 0.3-mg recombinant human thyrotropin prior to iodine 131 therapy to improve the size reduction of benign nontoxic nodular goiter: a prospective randomized double-blind trial. Arch Intern Med. 2006 Jul 24;166(14):1476-82. doi: 10.1001/archinte.166.14.1476.

    PMID: 16864757RESULT

MeSH Terms

Conditions

Graves DiseasePatient Satisfaction

Interventions

Thyrotropin Alfa

Condition Hierarchy (Ancestors)

ExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

ThyrotropinPituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Viveque Egsgaard Nielsen, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

April 1, 2002

Study Completion

July 1, 2005

Last Updated

December 28, 2010

Record last verified: 2009-04

Locations

DK(1)