Back to resultsHIFU in Patients With Non-malignant Thyroid Nodules
Primary Purpose
Non-malignant Thyroid Nodules
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Echopulse
Sponsored by
About this trial
This is an interventional treatment trial for Non-malignant Thyroid Nodules
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Istituto in tecnologie avanzate e modelli assistenziali in oncologia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US)
Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US)
Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US)
Secondary Outcome Measures
Number of subjects with adverse events as a measure of safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02258347
Brief Title
HIFU in Patients With Non-malignant Thyroid Nodules
Official Title
Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
October 13, 2015 (Actual)
Study Completion Date
October 13, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theraclion
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-malignant Thyroid Nodules
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Echopulse
Primary Outcome Measure Information:
Title
Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US)
Time Frame
Month 6 and Month 12
Title
Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US)
Time Frame
Month 6 and Month 12
Title
Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US)
Time Frame
Month 6 and Month 12
Secondary Outcome Measure Information:
Title
Number of subjects with adverse events as a measure of safety and tolerability
Time Frame
Day 1, Month 1, Month 3, Month 6 and Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Frasoldati, Dr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto in tecnologie avanzate e modelli assistenziali in oncologia
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
HIFU in Patients With Non-malignant Thyroid Nodules
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