High Intensity Focused Ultrasound Device in Patients With Autonomous Hyperfunctioning Thyroid Nodules
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|ClinicalTrials.gov Identifier: NCT02169687|
Recruitment Status : Terminated (Protocol's modifications requested by IRB weren't feasible to continue the study)
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Autonomous Hyperfunctioning Thyroid Nodules||Device: HIFU||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
High Intensity focalized Ultrasounds
- Proportion of patient with TSH normalization / increase [ Time Frame: 3 months ]
- Number of patients with TSH normalization / increase [ Time Frame: 3 weeks, 6 months, 12 months ]
- Changes of FT3 and FT4 [ Time Frame: D3, D14, 6 weeks, M3, M6, M12 ]
- Change in the volume nodule [ Time Frame: 6 weeks, M3, M6 and M12 ]
- Number of adverse events [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169687
|Hôpital Pitié Salpetrière|
|Paris, France, 75013|