HIFU in Patients With Non-malignant Thyroid Nodules
Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
1 other identifier
interventional
4
1 country
1
Brief Summary
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 26, 2014
CompletedFirst Posted
Study publicly available on registry
October 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2015
CompletedAugust 28, 2019
May 1, 2018
1.3 years
September 26, 2014
August 27, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US)
Month 6 and Month 12
Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US)
Month 6 and Month 12
Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US)
Month 6 and Month 12
Secondary Outcomes (1)
Number of subjects with adverse events as a measure of safety and tolerability
Day 1, Month 1, Month 3, Month 6 and Month 12
Study Arms (1)
Single arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Theraclionlead
Study Sites (1)
Istituto in tecnologie avanzate e modelli assistenziali in oncologia
Reggio Emilia, 42100, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Frasoldati, Dr
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2014
First Posted
October 7, 2014
Study Start
July 1, 2014
Primary Completion
October 13, 2015
Study Completion
October 13, 2015
Last Updated
August 28, 2019
Record last verified: 2018-05