rhTSH-Thyroid Ablation With 1850 MBq of 131I
Information source: University of Siena
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thyroid Cancer
Intervention: radioiodine therapy after rhTSH (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: University of Siena Official(s) and/or principal investigator(s):
Furio Pacini, MD, Principal Investigator, Affiliation: Section of Endocrinology, University of Siena
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.
Clinical Details
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
Study design: Natural History, Longitudinal, Random Sample, Prospective Study
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 0. 9 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 88. 9% of group A and group B patients. Basal and
rhTSH-stimulated serum Tg was undetectable (<1 ng/ml) in 88. 6 % of group A and 84. 8% of group
B patients (p=0. 65). 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Newly diagnosed differentiated thyroid cancer patients, more than 18 years old,
recently treated by near total thyroidectomy were eligible for the study
Exclusion Criteria:
- Evidence of distant metastases and/or significant local invasion
Locations and Contacts
Section of Endcrinology, University of Siena, Siena 53100, Italy
Additional Information
Starting date: December 2004
Ending date: September 2006
Last updated: March 28, 2007
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