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


N/A
18 Years
N/A
Open (Enrolling)
Both
Thyroid Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

TSH level at the end of study

Outcome Description:

The percentage of patients obtaining TSH level at least 30 imU/L at the end of study period. Blood tests will be obtained after 4 weeks. If TSH > 30 the patient has completed the study. If TSH < 30 patient will continue for 1 week and blood tests will be obtained after week 5. If TSH > 30 the patient has completed the study. If TSH < 30 patient will be monitored during 1 week and blood tests will be obtained after 6 weeks.

Outcome Time Frame:

4-6 weeks

Safety Issue:

No

Principal Investigator

Vallo Volke, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tartu University

Authority:

Estonia: The State Agency of Medicine

Study ID:

1.0 /29.08.2012

NCT ID:

NCT01840332

Start Date:

April 2013

Completion Date:

December 2014

Related Keywords:

  • Thyroid Cancer
  • thyroid cancer
  • Thyroid Neoplasms
  • Thyroid Diseases

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