Autonomous Hyperfunctioning Thyroid Nodules Clinical Trial
Official title:
Pilot, Monocentric, Non-comparative Study of the Effectiveness and Safety of High Intensity Focused Ultrasound Device in Patients With Autonomous Hyperfunctioning Thyroid Nodules
The purpose of this study is to assess the efficacy and safety of High Intensity Focalized Ultrasound (HIFU) in the treatment for toxic Thyroids nodules
Hyperthyroidism is defined by a decrease in thyrotropin (TSH) level associated with elevated
or normal free T4 and T3 (subclinical hyperthyroidism). The most frequent etiology in the
older population is toxic adenoma or toxic multinodular goiter. Several studies have
demonstrated that such hyperthyroid status was associated with an increase in cardiac
arrhythmias (atrial fibrillation) and an increase in cardiovascular mortality. Nevertheless,
the management of patients presenting with subclinical hyperthyroidism remains
controversial.
Surgery is indicated in case of large toxic adenomas especially in young patients. In
European countries, radioiodine treatment is indicated in older patients, especially
presenting with cardiothyreosis or when surgery is contraindicated. Radioiodine is a simple,
cost-effective, and safe procedure in the treatment of autonomously hyperfunctioning thyroid
nodule. In a prospective study [Nygaard, 1999], there was a 45% decrease in the total
thyroid volume within 3 months after radio-iodine treatment, and 75% of patients with no
previous anti-thyroid drug treatment normalized for thyroid function within 3 months. In
another recently published prospective study [Endorgan, 2004], there was a decrease in hot
nodules volume assessed by US of 28.8% 3 months, 46.2% 6 months and 54% 12 months after
radioiodine treatment, and 66.7% of patients were euthyroid at 3 months, 71.8% at 6 months,
76.9% at 12 months. The AACE guidelines for the diagnosis and management of thyroid nodules
[Feld, 1996] recommend that all patients with toxic autonomous thyroid nodules require
treatment and remind that radioactive iodine is the treatment of choice for most patients
with toxic nodules. Nevertheless, at the present time there are no published data that
demonstrate the effectiveness of radioiodine treatment on the prevention of cardiac
complications in case of subclinical hyperthyroidism. When radioiodine treatment is
proposed, physicians must follow regulations and policies on 131I in Europe and US. The
European Union recently adopted the main international commission on radiological protection
(ICRP) recommendations on radiation protection. Such regulation may raise a number of
practical problems for 131I treated patients. With the exception of a few countries as
Germany and Switzerland, there often is no legislation defining the maximal dose of
radioiodine that can be administered on an ambulatory basis. Policies and recommendations
have been proposed to reduce the radiation hazards for the public or the family leaving
around the radioiodine treated patients.
Therefore, because of these radioprotection recommendations, and because of contraindication
to surgery and to radioiodine in some cases, an alternative treatment for toxic nodular
nodules, HIFU, may be suggested.
The aim of the study is to assess the efficacy and safety of HIFU treatment for autonomous
hyperfunctioning thyroid nodules. The main objective of the study is to assess the rate of
patients with TSH normalization (or increase). US changes of treated nodules, especially the
nodule volume, will be evaluated.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment