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Effect of the withdrawal of anti-thyroid treatment on the kynetics of iodine for the radioiodine therapy for autoimmune hyperthyroidism

Effect of the withdrawal of anti-thyroid treatment on the iodide 123 kynetics used for the dosmetry before radioiodine therapy with 131I for autoimmune hyperthyroidism.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-003579-21-IT
Enrollment
Unknown
Registered
2012-11-08
Start date
2012-09-25
Completion date
Unknown
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune hyperthyroidism (Graves-Basedow disease) MedDRA version: 14.1 Level: HLGT Classification code 10043739 Term: Thyroid gland disorders System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: TAPAZOLE*100CPR 5MG Pharmaceutical Form: Tablet CAS Number: 60-56-0 Current Sponsor code: M Other descriptive name: METHIMAZOLE Concentration unit: mg milligram(s) Concentration type: equa

Sponsors

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients, caucasian, asiatic, hispanic, male and female, aged 18-75 years, smokers and non smokers. Patients affected by Graves disease of every duration with normalization of free thyroid hormones at least from one month with anti-thyroid drug, without or with inactive orbitopathy (CAS=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Active Graves orbitopathy (CAS>3), severe Graves orbitopathy (optic neuropathy). Familiarity for arrhytmic cardiopathy. Pregnancy. Informed consent denied.

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluation of kynetics of radioactive iodide according to different modalities of discontinuation of anti-thyroid therapy;Secondary Objective: Evaluation of therapeutic outcome of radioiodine at 6 months follow-up;Primary end point(s): Differences in the uptake curve of iodide 123 of at least 50% at 2, 4 and 24 hours from administration.;Timepoint(s) of evaluation of this end point: 6 months—

Secondary

MeasureTime frame
Secondary end point(s): - differences in the uptake curve of iodide 123 - number of euthyroid/hyperthyroid patients at 6 months after radioiodine therapy (RAI) - number of patients with persistance or recurre of hyperthyroidism at 6 months from RAI - number of patients with reactivation or new appearance of orbitopathy at 6 months after RAI;Timepoint(s) of evaluation of this end point: 6 months—

Countries

Italy

Contacts

Public ContactU.O. ENDOCRINOLOGIA E DIABETOLOGIA

fONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO

paolo.beckpeccoz@unimi.it02.5503.3498

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026