Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454077
Status:
COMPLETED
Last Update Posted:
2007-03-29
First Post:
2007-03-28
Brief Title:
rhTSH-Thyroid Ablation With 1850 MBq of 131I
Sponsor:
University of Siena
Organization:
University of Siena
Study Overview
Official Title:
Recombinant Human TSH rhTSH-Aided Radioiodine 131 Therapy for Thyroid Remnant Ablation in Differentiated Thyroid Cancer Patients a Comparison Between 1850 MBq and 3700 MBq Activities
Status:
COMPLETED
Status Verified Date:
2006-10
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:
Most patients with differentiated thyroid carcinoma DTC are treated with therapeutic doses of radioiodine 131I after initial surgery total or near total thyroidectomy aimed to destroy microscopic residual normal or tumoral thyroid cells and to facilitate the early detection of tumor recurrence based on serum thyroglobulin Tg measurement and 131I whole body scan WBS 1-5 Recently preparation of patients for thyroid ablation with rhTSH and 3700 MBq of 131I on l-thyroxine l-T4 therapy has been approved in Europe by the European Medicines Agency EMEA as an alternative to thyroid hormone withdrawal 6 after a randomized controlled multicenter study demonstrated that both methods of preparation are equally effective with 100 rate of successful ablation and that patients prepared with rhTSH received lower total body irradiation and experienced a better quality of life compared to those rendered hypothyroid 7
The present study was aimed to compare the efficacy of fixed activities of 1850 MBq versus 3700 MBq of 131I for post surgical thyroid ablation in DTC patients prepared with rhTSH TSHα Thyrogen Genzyme Therapeutics Cambridge MA on l-T4 therapy
The present study was aimed to compare the efficacy of fixed activities of 1850 MBq versus 3700 MBq of 131I for post surgical thyroid ablation in DTC patients prepared with rhTSH TSHα Thyrogen Genzyme Therapeutics Cambridge MA on l-T4 therapy
Detailed Description:
Aim Recently a multicenter study in differentiated thyroid cancer DTC patients showed that 3700 MBq of 131I after rhTSH stimulation had successful post-surgical thyroid ablation rate similar to that obtained after thyroid hormone withdrawal We investigated whether 1850 MBq of 131I have a rate of successful ablation similar to 3700 MBq in patients prepared with rhTSH
Methods Seventy-two patients with DTC were randomly assigned after surgery to receive 1850 MBq group A n 36 or 3700 MBq group B n 36 of 131I after rhTSH The two groups were comparable for age sex histotype and tumor stage One injection of 09 mg of rhTSH was administered for two consecutive days 131I therapy was delivered 24 hours after the last injection A post-therapy whole body scan WBS was performed 72 hours later Successful ablation was assessed 6-8 months after therapy
Results Successful ablation defined as no visible uptake in the diagnostic WBS after rhTSH stimulation was achieved in 889 of group A and group B patients Basal and rhTSH-stimulated serum Tg was undetectable 1 ngml in 886 of group A and 848 of group B patients p065 Similar rates of ablation were obtained in both groups also in patients with lymph node metastases Dosimetric data showed similar thyroid bed uptake effective half-life and adsorbed dose in the two groups Failure to ablate was not correlated with TNM staging peak TSH levels thyroid bed uptake and urinary iodine excretion at the time of ablation but was influenced by the absorbed dose of 131I or 300 Gy
Conclusion Our results demonstrate that therapeutic 131I activities of 1850 MBq are equally effective as 3700 MBq for thyroid ablation in DTC patients prepared with rhTSH even in the presence of lymph node metastases
Methods Seventy-two patients with DTC were randomly assigned after surgery to receive 1850 MBq group A n 36 or 3700 MBq group B n 36 of 131I after rhTSH The two groups were comparable for age sex histotype and tumor stage One injection of 09 mg of rhTSH was administered for two consecutive days 131I therapy was delivered 24 hours after the last injection A post-therapy whole body scan WBS was performed 72 hours later Successful ablation was assessed 6-8 months after therapy
Results Successful ablation defined as no visible uptake in the diagnostic WBS after rhTSH stimulation was achieved in 889 of group A and group B patients Basal and rhTSH-stimulated serum Tg was undetectable 1 ngml in 886 of group A and 848 of group B patients p065 Similar rates of ablation were obtained in both groups also in patients with lymph node metastases Dosimetric data showed similar thyroid bed uptake effective half-life and adsorbed dose in the two groups Failure to ablate was not correlated with TNM staging peak TSH levels thyroid bed uptake and urinary iodine excretion at the time of ablation but was influenced by the absorbed dose of 131I or 300 Gy
Conclusion Our results demonstrate that therapeutic 131I activities of 1850 MBq are equally effective as 3700 MBq for thyroid ablation in DTC patients prepared with rhTSH even in the presence of lymph node metastases
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