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
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | October 2007 |
| Est. primary completion date | October 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Male or female patient, aged at least 18 years. - Patient presenting with at least one autonomous hyperfunctioning thyroid nodule - TSH 0,1 mU/ml - Hyperfunctioning at thyroid scintigraphy with partial or total extinction of parenchyma - Targeted nodules visible with ultrasonography - Volume to be treated 15 cc - Targeted area located at least at 2 mm from the trachea, the esophagus, and the carotid artery. - Composition of the targeted nodule: no more than 75% cystic. - Absence of abnormality at laryngoscopy in recurrent nerves - Voluntary consent (patient or legal guardian) to participate in the study, following a full explanation of the nature and purpose of the study, by signing the Informed Consent document at the eligibility assessment visit - Patients for whom iodine therapy is contra-indicated or unfeasible and surgery is contra-indicated or refused - Patients refusing iodine therapy - Willingness and availability to return for all required follow-up visits and to undergo all required study procedures. - Patient affiliated to the French Health Insurance System Exclusion Criteria: - For the targeted nodule(s): presence of signs evidencing a nodule malignancy (compression or curvature of the surrounding organs, positive or suspicious previous FNAB). - Suspicious cervical lymph nodes at US - > 75% Cystic nodule - Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment - Pregnant or lactating woman. Female patient of childbearing age will be screened for pregnancy prior to enrollment in the study and will be included only if having a suitable contraception method. - Known latex or lidocaine hypersensitivity - History of neck irradiation or subtotal thyroidectomy - Non controlled evolutive cardiothyreosis - Patients treated with antithyroid medications within the month before the pre-treatment visit - Subjects whose concurrent illnesses, disability, or geographical residence would hamper regular attendance at required study visits - Patients who have received any investigational drug or device within the last 30 days and/or patients who are currently participating in another clinical trial |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Pitié Salpetrière | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Theraclion | Groupe Hospitalier Pitie-Salpetriere, Hôpital Saint Louis Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patient with TSH normalization / increase | 3 months | Yes | |
| Secondary | Number of patients with TSH normalization / increase | 3 weeks, 6 months, 12 months | Yes | |
| Secondary | Changes of FT3 and FT4 | D3, D14, 6 weeks, M3, M6, M12 | Yes | |
| Secondary | Change in the volume nodule | 6 weeks, M3, M6 and M12 | Yes | |
| Secondary | Number of adverse events | 1 year | Yes |