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Graves DiseasePhase 3NCT01039818

Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism

A Phase 3 study testing Radioiodine in people with Graves Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Graves Disease
What is being tested?
Radioiodine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBrazil
Study dates
Feb 1997to Aug 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Brazil1 site

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

    Porto Alegre, Rio Grande do Sul, 90035-003

Other trials in Brazil

About this study

Official title: Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism: A Clinical Trial With Historical Control

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

Read the detailed description

Graves' disease (GD) is the most frequent cause of hyperthyroidism, affecting mainly women aged 40-60 years. Radioiodine (¹³¹I), introduced in 1941, has become a cornerstone in the treatment of GD hyperthyroidism. Because of its safety, low costs and rapid effect, it is considered a first line therapy in the United States. However, treatment failure occurs in about 15-25% of patients treated with radioiodine. Patients not cured with the first dose of radioiodine usually present severe hyperthyroidism, characterized by large goiter, high 24-hour radioiodine uptake (24h-RAIU) and very high levels of thyroid hormones. We have previously shown that large goiter (≥48ml) is an independent predictor of treatment failure. In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter was only 6.5% (P=0.005; unpublished). It is generally accepted that higher doses of radioiodine improves cure rates. Indeed, a recent meta-analysis found a correlation between radioiodine dose and therapeutic success in GD patients. To our knowledge, there are no published studies evaluating cure rates with different radioiodine doses in severe GD.

Conditions
Graves Disease
Being tested
Radioiodine
Keywords
Graves Disease, Hyperthyroidism, Radioiodine, Clinical trial
Medical subject headings
Graves Disease, Hyperthyroidism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadioiodineRadiation

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

  • RadioiodineRadiation

    A unique dose of 250µCi of ¹³¹I/ml/24-RAIU

Study groups in NCT01039818
Study groupRoleWhat they receive
Radiodine-200µCiActive comparatorA 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.
Receives: Radiation: Radioiodine
Radiodine-250µCiExperimentalPatients with Graves' Disease and goiter ≥48ml, prospectively assigned to receive 250 µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU.
Receives: Radiation: Radioiodine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

Secondary outcomes (2)

  1. Euthyroidism

    Measured: 12 months

  2. Permanent hypothyroidism

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2009 (estimated)
  2. Study startFeb 1997
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01039818
Sponsor's protocol ID
07-055
Status last verified
Sep 2012
First submitted
24 Dec 2009
Last updated
6 Sep 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 10566642

  • 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.

    PubMed 11502768

  • 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.

    PubMed 15476447

  • 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.

    PubMed 15611828

  • 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.

    PubMed 23984185

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radioiodine in people with Graves Disease, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cure, defined as euthyroidism or permanent hypothyroidism based on FT4 measurements. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01039818, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.

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