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

U

University of Tartu

Status

Completed

Conditions

Thyroid Cancer

Treatments

Drug: L-thyroxin

Study type

Interventional

Funder types

Other

Identifiers

NCT01840332
1.0 /29.08.2012

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

L-thyroxin
Experimental group
Description:
this is one arm study
Treatment:
Drug: L-thyroxin

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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