Status:
COMPLETED
HIFU in Patients With Non-malignant Thyroid Nodules
Lead Sponsor:
Theraclion
Conditions:
Non-malignant Thyroid Nodules
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.
Eligibility Criteria
Inclusion
- Male or female patient 18 years or older.
- Patient presenting with at least one thyroid nodule with no signs of malignancy:
- Non suspect clinically and at ultrasonography imaging
- Benign cytological diagnosis at fine-needle aspiration biopsy (FNAB) from the last 6 months
- Normal serum calcitonin
- No history of neck irradiation
- Normal thyroid-stimulating hormone (TSH).
- Targeted nodule accessible and eligible to HIFU
- Absence of abnormal vocal cord mobility at laryngoscopy.
- Nodule diameter ≥ 10mm measured by ultrasound.
- Nodule volume inferior to 10 cc
- Composition of the targeted nodule(s) : no more than 30% cystic
Exclusion
- Head and/or neck disease that prevents hyperextension of neck.
- Known history of thyroid cancer or other neoplasias in the neck region.
- History of neck irradiation.
- Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment
- Posterior position of the nodule if the thickness of the nodule is \<15mm
- Pregnant or lactating woman
- Any contraindication to the assigned analgesia/anaesthesia.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02258347
Start Date
July 1 2014
End Date
October 13 2015
Last Update
August 28 2019
Active Locations (1)
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1
Istituto in tecnologie avanzate e modelli assistenziali in oncologia
Reggio Emilia, Italy, 42100