NCT00509483

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
Last Updated

October 17, 2008

Status Verified

October 1, 2008

First QC Date

July 27, 2007

Last Update Submit

October 16, 2008

Conditions

Tratment of Multinodular Goitre

Keywords

multinodulargoitrerecombinant human TSH

Interventions

Radioactive iodineRADIATION

Radioactive iodine preceded by rhTSH

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with multinodular goitre

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Goiter

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Officials

  • Rossana Romão, MD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2007

First Posted

July 31, 2007

Study Start

January 1, 2002

Study Completion

December 1, 2006

Last Updated

October 17, 2008

Record last verified: 2008-10