NCT01039818

Brief Summary

The purpose of this study is to determine whether higher doses of radioiodine increase treatment efficacy in severe Graves' disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 1997

Longer than P75 for phase_3

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

February 1, 1997

Completed
12.9 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 25, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

September 6, 2012

Status Verified

September 1, 2012

Enrollment Period

14.5 years

First QC Date

December 24, 2009

Last Update Submit

September 4, 2012

Conditions

Graves Disease

Keywords

Graves DiseaseHyperthyroidismRadioiodineClinical trial

Outcome Measures

Primary Outcomes (1)

  • Cure, defined as euthyroidism or permanent hypothyroidism based on FT4 measurements.

    12 months

Secondary Outcomes (2)

  • Euthyroidism

    12 months

  • Permanent hypothyroidism

    12 months

Study Arms (2)

Radiodine-200µCi

ACTIVE COMPARATOR

A subgroup of patients with Graves' Disease and goiter ≥48ml treated with 200µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU, from a randomized controlled trial run at our institution between February 1997 and March 2000, serves as a historical control.

Radiation: Radioiodine

Radiodine-250µCi

EXPERIMENTAL

Patients with Graves' Disease and goiter ≥48ml, prospectively assigned to receive 250 µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU.

Radiation: Radioiodine

Interventions

RadioiodineRADIATION

A unique dose of 200µCi of ¹³¹I/ml/24-RAIU

Radiodine-200µCi

Eligibility Criteria

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

You may qualify if:

  • Consecutive patients with a recent diagnosis of Graves' disease and goiter ≥ 48 ml, attending the Endocrine Division at Hospital de Clinicas de Porto Alegre are eligible.

You may not qualify if:

  • Patients with previous treatment with radioiodine or thyroidectomy,
  • Signs of moderate or severe ophthalmopathy (proptosis \> 22 mm, ophthalmoplegia, chemosis, or lagophthalmos),
  • Severe heart disease (symptomatic coronary heart disease, class III heart failure, New York Heart Association criteria),
  • Debilitating conditions, and
  • Large and compressive goiters (\> 150 g).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (5)

  • Andrade VA, Gross JL, Maia AL. Effect of methimazole pretreatment on serum thyroid hormone levels after radioactive treatment in Graves' hyperthyroidism. J Clin Endocrinol Metab. 1999 Nov;84(11):4012-6. doi: 10.1210/jcem.84.11.6149.

    PMID: 10566642BACKGROUND

  • Andrade VA, Gross JL, Maia AL. The effect of methimazole pretreatment on the efficacy of radioactive iodine therapy in Graves' hyperthyroidism: one-year follow-up of a prospective, randomized study. J Clin Endocrinol Metab. 2001 Aug;86(8):3488-93. doi: 10.1210/jcem.86.8.7707.

    PMID: 11502768BACKGROUND

  • Andrade VA, Gross JL, Maia AL. Serum thyrotropin-receptor autoantibodies levels after I therapy in Graves' patients: effect of pretreatment with methimazole evaluated by a prospective, randomized study. Eur J Endocrinol. 2004 Oct;151(4):467-74. doi: 10.1530/eje.0.1510467.

    PMID: 15476447BACKGROUND

  • Andrade VA, Gross JL, Maia AL. [Radioactive iodine therapy in Graves' hyperthyroidism]. Arq Bras Endocrinol Metabol. 2004 Feb;48(1):159-65. doi: 10.1590/s0004-27302004000100017. Epub 2004 Jun 1. Portuguese.

    PMID: 15611828BACKGROUND

  • Dora JM, Escouto Machado W, Andrade VA, Scheffel RS, Maia AL. Increasing the radioiodine dose does not improve cure rates in severe graves' hyperthyroidism: a clinical trial with historical control. J Thyroid Res. 2013;2013:958276. doi: 10.1155/2013/958276. Epub 2013 Jul 31.

    PMID: 23984185DERIVED

MeSH Terms

Conditions

Graves DiseaseHyperthyroidism

Interventions

Iodine-131

Condition Hierarchy (Ancestors)

ExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ana L Maia, MD, PhD

    Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 24, 2009

First Posted

December 25, 2009

Study Start

February 1, 1997

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 6, 2012

Record last verified: 2012-09

Locations

BR(1)