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

NCT02169687 | Terminated Early Phase 1

• 1 other identifier: HIFU/F/02.01/Protocol V0
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Autonomous Hyperfunctioning Thyroid Nodules

Keywords

Thyroid, HIFU, hyperfunctioning, autonomous

Outcome Measures

Primary Outcomes (1)

• Proportion of patient with TSH normalization / increase

  3 months

Secondary Outcomes (4)

• Number of patients with TSH normalization / increase

  3 weeks, 6 months, 12 months

• Changes of FT3 and FT4

  D3, D14, 6 weeks, M3, M6, M12

• Change in the volume nodule

  6 weeks, M3, M6 and M12

• Number of adverse events

  1 year

Study Arms (1)

Hifu

EXPERIMENTAL

Device: HIFU

Interventions

HIFU DEVICE

High Intensity focalized Ultrasounds

Hifu

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Theraclion: lead
• Groupe Hospitalier Pitie-Salpetriere: collaborator
• Hôpital Saint Louis Paris: collaborator

Study Sites (1)

Hôpital Pitié Salpetrière

Paris, Paris, 75013, France

Location

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

FR (1)