Three-Year Follow-up of Radioiodine Therapy for Goitre

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2006-12-31

Brief Summary

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Background: Preadministration of recombinant human thyrotropin (rhTSH) increases the amount and homogeneity of thyroid radioiodine uptake, and when used as an adjuvant can augment the efficiency of 131I therapy by allowing multinodular goitre (MNG) volume reduction.

Objective: The investigators aimed to assess low-dose rhTSH-aided fixed-activity radioiodine therapy outcome in MNG patients.

Design: This was a long-term (36 months) observational study. Methods: The investigators measured 24 h thyroid radioiodine uptake (RAIU) of 1.4 µCi (0.5 MBq) of 131-iodine at baseline and 24 h after intramuscular injection of 0.1 mg rhTSH in 42 patients (aged 42-80 years) who subsequently received 30 mCi 131-iodine 24 h after an identical rhTSH injection. Urinary iodine was measured at baseline and at 3 months after following a low iodine diet. TSH, free thyroxine (FT4), T3 (T3) and thyroglobulin (TG) were measured at baseline, 24 h, 48 h, 72 h, 168 h, one month, 3, 6, 9, 12, 18, 24 and 36 months after therapy. Thyroid volume was assessed by computer tomography at baseline and every 6 months thereafter.

Detailed Description

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Conditions

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Tratment of Multinodular Goitre

Keywords

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multinodular goitre recombinant human TSH

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Radioactive iodine

Radioactive iodine preceded by rhTSH

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients with multinodular goitre

Exclusion Criteria

* Aversion to any form of treatment
* Previous radioiodine therapy
* Being unable to complete a prolonged follow-up; and
* Having serious cardiovascular disorders.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Rossana Romão, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Other Identifiers

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PRN 833/02

Identifier Type: -

Identifier Source: org_study_id