Three-Year Follow-up of Radioiodine Therapy for Goitre
Information source: University of Sao Paulo
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tratment of Multinodular Goitre
Intervention: Radioactive iodine (Radiation)
Phase: N/A
Status: Completed
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s):
Rossana Romão, MD, Principal Investigator, Affiliation: University of São Paulo
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: We 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: We 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.
Results: rhTSH (0. 1 mg) significantly increased mean 24 h thyroid RAIU from 26. 9±14. 4%
(mean±SD) to 44. 8±14. 0% (p<0. 01). All patients had relatively high baseline iodine urinary
excretion, 308±108 µg I/L (range: 168-642 µg I/L) that decreased to 165±98 µg I/L 90 days
after a low iodine diet, at which point only 2 patients presented elevated (>300µgI/L) iodine
urinary excretion. Mean±SD serum TSH peaked at 24 h reaching 12. 4±5. 85µU/L,returning to
normal values at 72h. Mean±SD serum FT4 and total T3 peaked at 48 h (31. 2±15. 1pmol/L; 5. 0±1. 8
nmol/L) and were still elevated at 30 days. Mean±SD serum TG peaked at 72 h (732. 4±351. 4
µg/L) and declined to 173. 1±201. 8 µg/L at 36 months (p<0. 01). Estimated thyroid volume
decreased 75. 2% from baseline mean±SD volume 184. 0±168. 2 ml to 49. 4±56. 6ml at 36 months
(p<0. 001). In the first month after 131I, seven patients had mild hyperthyroidism controlled
with beta-blocker; 12 had transient painful thyroid enlargement; 3 had acute esophagitis, and
2 patients had ventricular tachycardia. Sixteen out of forty-two (38%) patients became
hypothyroid in the first year and were medicated with L-thyroxine. There was no elevation of
serum anti-TPO, anti-TG or TRAb during the 36 months of follow-up.
Conclusions: Intramuscular rhTSH (0. 1mg) followed 24 h later by 131I iodine (30 mCi) improved
the reduction of large MNG by 75% at 36 months, and also lowered the risk of cardiovascular
complications. One third of the patients had post-therapy permanent hypothyroidism. This
outpatient modality of RAI therapy reduces the costs involved and may be useful for the large
number of patients seeking treatment for MNG.
Clinical Details
Official title: Long-Term Follow-up and Outcome of Administering Recombinant Human Thyrotropin as an Adjuvant of Therapy With Radioiodine in the Outpatient Treatment of Multinodular Goitres
Study design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: January 2002
Ending date: December 2006
Last updated: July 27, 2007
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