Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509483
Status:
COMPLETED
Last Update Posted:
2008-10-17
First Post:
2007-07-27
Brief Title:
Three-Year Follow-up of Radioiodine Therapy for Goitre
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 14 µCi 05 MBq of 131-iodine at baseline and 24 h after intramuscular injection of 01 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
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 14 µCi 05 MBq of 131-iodine at baseline and 24 h after intramuscular injection of 01 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None