NCT02169687

High Intensity Focused Ultrasound Device in Patients With Autonomous Hyperfunctioning Thyroid Nodules

Pilot, Monocentric, Non-comparative Study of the Effectiveness and Safety of High Intensity Focused Ultrasound Device in Patients With Autonomous Hyperfunctioning Thyroid Nodules

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Theraclion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Autonomous Hyperfunctioning Thyroid Nodules

Interventions

Type	Name	Description
DEVICE	HIFU	High Intensity focalized Ultrasounds

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2014-06-23
• Last updated: 2014-06-23

Locations

1 site across 1 country: France