OnT4-Thyroglobulin Assay Before rhTSH-Aided Radioiodine Ablation

This study has been completed.
Sponsor:
Information provided by:
Oncology Institute of Southern Switzerland
ClinicalTrials.gov Identifier:
NCT00439127
First received: February 22, 2007
Last updated: February 27, 2007
Last verified: February 2007
  Purpose

Thyroidectomy followed by administration of large activities of 131-iodine (131I) is the treatment of choice for differentiated thyroid carcinoma (DTC). The serum thyroglobulin (Tg) measurement during hypothyroidism (offT4-Tg), just before radioiodine thyroid ablation, has proved to be effective for predicting persistent/recurrent disease. However, the Tg measurement cannot be used as a corresponding value for preablative offT4-Tg when rhTSH is used as stimulous before treatment. The present study was undertaken to evaluate if post-thyroidectomy Tg values, measured before rhTSH-stimulation and radioiodine administration, is of prognostic value in patients affected by DTC. We enrolled 28 patients with DTC and submitted to total thyroidectomy. Thyroxine (T4) treatment was started just after surgery to suppress TSH levels. Six to nine weeks later Tg levels were measured both basally (onT4-Tg) and after rhTSH (rhTSH-Tg) stimulation. Subsequently, T4 was stopped and serum Tg measured (offT4-Tg) just before 3700 MBq of 131I-iodide administration. A post-treatment whole body scan (PT-WBS) was performed and neck radioiodine uptake (RAIU) measured. A significant relationship was found between onT4-Tg and both rhTSH-Tg and offT4-Tg. The onT4-Tg levels of 0.2 ng/mL or higher predicted PT-WBS results with a 100% negative and 43% positive predictive values, respectively. Additionally onT4-Tg levels of 0.9 ng/mL or more predicts 12-months recurrences with 100% negative and 60% positive predictive value. In comparison, 1.0 ng/mL or higher offT4-Tg values predicted PT-WBS results and 12-months restaging with 94% and 100% negative and 45% and 27% positive predictive value, respectively. Basing on our data we conclude that preablative onT4-Tg may be of value as prognostic marker when rhTSH-aided radioiodine ablation is done. Additionally, the role of preblative onT4-Tg measurement as a yard-stick for radioiodine ablation should be further evaluate.


Condition
Differentiated Thyroid Carcinoma

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Is the Thyroglobulin Measurement Under Thyroxine of Prognostic Value Before rhTSH-Aided Radioiodine Ablation in Differentiated Thyroid Carcinoma?

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Further study details as provided by Oncology Institute of Southern Switzerland:

Estimated Enrollment: 28
Study Start Date: January 2005
Estimated Study Completion Date: January 2007
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  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hiostologically proved DTC (M0)

Exclusion Criteria:

  • Preoperative metastasis
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00439127

Sponsors and Collaborators
Oncology Institute of Southern Switzerland
Investigators
Principal Investigator: Luca Giovanella, MD Oncology Institute of Southern Switzerland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00439127     History of Changes
Other Study ID Numbers: IOSI-MN-1-07
Study First Received: February 22, 2007
Last Updated: February 27, 2007
Health Authority: Switzerland: Ethikkommission

Keywords provided by Oncology Institute of Southern Switzerland:
thyroglobulin
thyroid carcinoma
tumour marker
radioiodine
recombinant human TSH

Additional relevant MeSH terms:
Carcinoma
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 22, 2014