rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Go... | NCT00145366

Studies
rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

NCT00145366

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Dec 28, 2010Estimated

Enrollment

110

Phase

Phase 2

Conditions

Benign Nontoxic and Toxic Goiter
Graves' Disease

Interventions

Recombinant human thyrotropin (Thyrogen)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2002

Primary Completion Date

Not provided

Completion Date

Jul 2005Actual

First Submitted Date

Sep 2, 2005

First Submission Date that Met QC Criteria

Sep 2, 2005

First Posted Date

Sep 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2010

Last Update Posted Date

Dec 28, 2010Estimated

Description Module

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:

Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine in nontoxic multinodular goiter.
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.
Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume in healthy individuals? A randomized double-blind cross-over trial.
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.

As a final note we investigate, in a pilot-study;
The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110

Name	Type	Description	Arm Group Labels	Other Names
Recombinant human thyrotropin (Thyrogen)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ultrasonography/MR of the thyroid gland/benign goiter, in order to determine thyroid size after intervention.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Treatment with drugs that alter thyroid function or size (the last 3 months prior to inclusion)
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
Ischemic attack up till 3 months before inclusion

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Viveque Egsgaard Nielsen, MD	Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, Odense University Hospital		Odense	Funen	5000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16864757	Result	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.

ID	Term
D006111	Graves Disease
D017060	Patient Satisfaction

ID	Term
D005094	Exophthalmos
D009916	Orbital Diseases
D005128	Eye Diseases
D006042	Goiter

ID	Term
D013972	Thyrotropin
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones