rhTSH-Thyroid Ablation With 1850 MBq of 131I

This study has been completed.
Sponsor:
Information provided by:
University of Siena
ClinicalTrials.gov Identifier:
NCT00454077
First received: March 28, 2007
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Thyroid Cancer
Procedure: radioiodine therapy after rhTSH
Phase 3

Study Type: Observational
Study Design: Allocation: Random Sample
Observational Model: Natural History
Time Perspective: Longitudinal
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

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Further study details as provided by University of Siena:

Estimated Enrollment: 72
Study Start Date: December 2004
Study Completion Date: September 2006
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00454077

Locations
Italy
Section of Endcrinology, University of Siena
Siena, Italy, 53100
Sponsors and Collaborators
University of Siena
Investigators
Principal Investigator: Furio Pacini, MD Section of Endocrinology, University of Siena
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00454077     History of Changes
Other Study ID Numbers: AIRC 1185
Study First Received: March 28, 2007
Last Updated: March 28, 2007
Health Authority: Italy: Ethics Committee

Keywords provided by University of Siena:
thyroid cancer; rhTSH; thyroid ablation

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014