rhTSH-Thyroid Ablation With 1850 MBq of 131I

March 28, 2007 updated by: University of Siena

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Siena, Italy, 53100
        • Section of Endcrinology, University of Siena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Investigators

  • Principal Investigator: Furio Pacini, MD, Section of Endocrinology, University of Siena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion (ACTUAL)

September 1, 2006

Study Registration Dates

First Submitted

March 28, 2007

First Submitted That Met QC Criteria

March 28, 2007

First Posted (ESTIMATE)

March 29, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2007

Last Update Submitted That Met QC Criteria

March 28, 2007

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIRC 1185

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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