Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223158
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2005-09-19
Brief Title:
Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer
Sponsor:
Patrice Perron
Organization:
Université de Sherbrooke
Study Overview
Official Title:
L-T3 Preparation for I131 Whole Body Scintigraphy A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2005-07
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:
To compare the hypothyroid state in patients with thyroid cancer prepared either by placebo or L-T3 following L-T4 withdrawal in preparation for whole body scintigraphy To evaluate the time needed for TSH elevation 30 mUIL on placebo vs L-T3
Detailed Description:
Patients with well differentiated thyroid cancer DTC need whole-body scintigraphy WBS and thyroglobulin Tg measurement in order to detect recurrence Classically withdrawal from levothyroxine L-T4 during 4-6 weeks is needed for TSH elevation 30mUIL to allow iodine uptake and Tg production As a result patients become hypothyroid with impaired quality of life and a potential for tumour flare-up Recombinant hTSH before WBS prevents hypothyroidism but is not yet approved for radioiodine treatment and is an expensive therapy L-T3 substitution during the first 2-3 weeks of withdrawal is an alternative used empirically to prepare patients however no data exists to prove its benefit upon reducing hypothyroidism
Objectives 1 To compare the hypothyroid state in patients prepared either by placebo or L-T3 following L-T4 withdrawal 2 To evaluate the time needed for TSH elevation 30 mUIL on placebo vs L-T3
Method At the time of L-T4 withdrawal or after thyroidectomy patients with DTC awaiting WBS or radioiodine treatment were randomized in two groups double-blind L-T3 50 mg qd or an identical placebo for 3 weeks after which treatment was stopped for 2 weeks A validated questionnaire of signs and symptoms of hypothyroidism Billewiczs scale was administered every 2 weeks until the WBS TSH fT4 and fT3 were measured weekly
Objectives 1 To compare the hypothyroid state in patients prepared either by placebo or L-T3 following L-T4 withdrawal 2 To evaluate the time needed for TSH elevation 30 mUIL on placebo vs L-T3
Method At the time of L-T4 withdrawal or after thyroidectomy patients with DTC awaiting WBS or radioiodine treatment were randomized in two groups double-blind L-T3 50 mg qd or an identical placebo for 3 weeks after which treatment was stopped for 2 weeks A validated questionnaire of signs and symptoms of hypothyroidism Billewiczs scale was administered every 2 weeks until the WBS TSH fT4 and fT3 were measured weekly
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