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Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer

Information source: University of Tartu
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thyroid Cancer

Intervention: L-thyroxin (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Tartu

Official(s) and/or principal investigator(s):
Vallo Volke, MD, PhD, Principal Investigator, Affiliation: Tartu University

Summary

The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients.

Clinical Details

Official title: Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: TSH level at the end of study

Secondary outcome: change in Billewitz index during the study

Detailed description: The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation for the measurement of thyreoglobulin and/or total body scanning. There are two principal methods to obtain TSH elevation: 1) injection of recombinant human TSH , and 2) to stop L-thyroxin replacement for several (3-4) weeks. As use of recombinant TSH is rather expensive, this method is not feasible in many countries. The problem with stopping L-thyroxin is development of severe hypothyroidism for several weeks with concomitant symptoms and signs. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients with fixed dose of L-thyroxin. Concomitantly, blood tests and symptoms and signs of hypothyroidism will be obtained to get information about possible deviations during treatment with low dose of thyroxin.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Differentiated thyroid cancer

- treated by thyroidectomy and at least 1 ablation with 131-I > 5 months ago

- TSH < 4 imU/L

Exclusion Criteria:

- Pregnancy

- Known metastasis

Locations and Contacts

East Tallinn Central Hospital, Tallinn 10138, Estonia

Tartu University Hospital, Tartu 50406, Estonia

Additional Information

Starting date: April 2013
Last updated: March 13, 2014

Page last updated: August 23, 2015

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