Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196729
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2005-09-13
Brief Title:
Comparison of the Safety and Successful Ablation of Thyroid Remnant in Post-thyroidectomized Euthyroid Patients ie Patients Administered Thyrogen Versus Hypothyroid Patients no Thyrogen Following 131I Administration
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Controlled Open-Label Multi-National Pilot Study of Thyroid Remnant Ablation Comparing the Safety and Ablation Rate Following 131I Administration Using Thyrogen Versus the Safety and Ablation Rate Following 131I Administration in the Hypothyroid State
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy After surgery patients were randomized to one of two methods of performing thyroid remnant ablation use of radioiodine to remove any remaining thyroid tissue One group of patients who took thyroid hormone medicine and were euthyroid ie their thyroid stimulating hormone TSH levels are normal and received injections of Thyrogen 09 mg daily on two consecutive days followed by oral radioiodine The second group of patients did not take thyroid hormone medicine so that they were hypothyroid ie their TSH levels were high and were given oral radioiodine All patients received the same amount of radioactive iodine 100 mCi or 37 GBq of 131I Approximately 8 months later whole body scans were performed on all patients to learn whether the thyroid remnants had been successfully ablated The safety profile of Thyrogen when used for radioiodine remnant ablation also was assessed The Quality of Life the radioiodine uptake and retention into the thyroid bed as well as radiation exposure to the remainder of the body also were assessed in both groups of patients
Detailed Description:
Following a totalnear-total thyroidectomy eligible patients provided written informed consent within 14 days post-surgery Patients were then randomized to 1 of 2 groups the Euthyroid or the Hypothyroid group
Once randomized patients in the Euthyroid group received thyroid hormone suppression therapy THST for 4 weeks At the end of the fourth week the patients TSH level was measured If the TSH level was 5 mUL Thyrogen 09 mg was administered intramuscularly IM once daily qd for 2 days Twenty-four hours following the second dose of Thyrogen an ablative activity of 131I 100 mCi 37 GBq was administered All patients then underwent post-treatment whole-body scanning WBS and remnant-neck imaging at 48 hours at 72 to 96 hours and at 96 to 168 hours preferably 120 hours following ablation In addition the study allowed for the option to perform scans at 24 hours and between 144 and 168 hours after ablation Following the final post-treatment scan patients in the Euthyroid group continued THST
Patients randomized to the Hypothyroid Group did not receive THST after randomization These individuals were monitored for at least 4 weeks or until their TSH was 25 mUL Patients were given an ablative dose of 131I 100 mCi 37 GBq If the patients TSH was 25 mUL at the end of the fourth week the patients TSH was measured again 1 week later Patients then underwent post-treatment WBS and remnant-neck imaging at 48 hours at 72 to 96 hours and at 96 to 168 hours preferably 120 hours following ablation In addition the study allowed for the option to perform scans at 24 hours and between 144 and 168 hours post ablation Following the final post-treatment scan patients in the Hypothyroid group commenced THST
Eight l months later patients in both the Euthyroid and Hypothyroid groups received Thyrogen 09 mg qd for 2 days followed by an activity of 131I 4 mCi 015 GBq in preparation for 48-hour WBS and remnant-neck imaging
Patients with a negative neck scan ie no visible uptake or if visible uptake less than 01 uptake in the thyroid bed 8 1 months following the 131I treatment were considered successfully ablated
Once randomized patients in the Euthyroid group received thyroid hormone suppression therapy THST for 4 weeks At the end of the fourth week the patients TSH level was measured If the TSH level was 5 mUL Thyrogen 09 mg was administered intramuscularly IM once daily qd for 2 days Twenty-four hours following the second dose of Thyrogen an ablative activity of 131I 100 mCi 37 GBq was administered All patients then underwent post-treatment whole-body scanning WBS and remnant-neck imaging at 48 hours at 72 to 96 hours and at 96 to 168 hours preferably 120 hours following ablation In addition the study allowed for the option to perform scans at 24 hours and between 144 and 168 hours after ablation Following the final post-treatment scan patients in the Euthyroid group continued THST
Patients randomized to the Hypothyroid Group did not receive THST after randomization These individuals were monitored for at least 4 weeks or until their TSH was 25 mUL Patients were given an ablative dose of 131I 100 mCi 37 GBq If the patients TSH was 25 mUL at the end of the fourth week the patients TSH was measured again 1 week later Patients then underwent post-treatment WBS and remnant-neck imaging at 48 hours at 72 to 96 hours and at 96 to 168 hours preferably 120 hours following ablation In addition the study allowed for the option to perform scans at 24 hours and between 144 and 168 hours post ablation Following the final post-treatment scan patients in the Hypothyroid group commenced THST
Eight l months later patients in both the Euthyroid and Hypothyroid groups received Thyrogen 09 mg qd for 2 days followed by an activity of 131I 4 mCi 015 GBq in preparation for 48-hour WBS and remnant-neck imaging
Patients with a negative neck scan ie no visible uptake or if visible uptake less than 01 uptake in the thyroid bed 8 1 months following the 131I treatment were considered successfully ablated
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