NCT03331172

Brief Summary

High Intensity Focused Ultrasound (HIFU) is a new approach in treating benign thyroid nodule without surgery. It is proven effective and safe relative to traditional surgery. From previous HIFU studies, it caused shrinkage of thyroid nodule up to 70% from original size. Unfortunately, 5-10% of nodule do not shrink. Those which do not shrink are usually large in size and therefore a second HIFU treatment may help. This study is going to evaluate the efficacy and safety of reapplication HIFU after the first single HIFU session in 6 months. The study will be carried out in the following steps:

  1. 1.Recruit subject from the clinic according to the study criteria.
  2. 2.Arrange the reapplication HIFU treatment within 3 months.
  3. 3.Arrange 4 visits after the HIFU treatment in Post 7 days, Post 1 month, Post 3 months, and Post 6 months; Data collection will be in these 4 visits through the questionnaire or interview by research assistant
  4. 4.The subjects will have further health management with the same team after the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

October 27, 2017

Last Update Submit

October 9, 2018

Conditions

Thyroid Nodule

Keywords

HIFUthyroid noduleBenignReapplication

Outcome Measures

Primary Outcomes (1)

  • Change in thyroid nodule volume (mL)

    To measure the change in volume (mL) of the index (or treated) thyroid nodule 6 months following HIFU reapplication

    6 months

Secondary Outcomes (6)

  • The efficacy of reapplication HIFU after the first single session in 6 months

    6 months

  • The safety of reapplication HIFU after the first single session in 6 months

    6 months

  • The rate of vocal cord palsy in reapplication HIFU after the first single session in 6 months

    6 months

  • The cosmetic score (in 0-10) of reapplication HIFU after the first single session in 6 months

    6 months

  • The pain score (in 0-10) of reapplication HIFU after the first single session in 6 months

    6 months

  • +1 more secondary outcomes

Study Arms (1)

High Intensity Focused Ultrasound

EXPERIMENTAL
Device: Echopulse

Interventions

EchopulseDEVICE

Echopulse is a real-time US-guided High-intensity focused ultrasound (HIFU) system, the HIFU session is a noninvasive procedure that involves application of a focused high-energy ultrasound beam for thermal tissue ablation inside the targeted zone, with minimal effect on the surrounding tissue

Also known as: High Intensity Focused Ultrasound (HIFU)
High Intensity Focused Ultrasound

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients age older than 18 years,
  • a nodule that has previously been completely treated by single-session HIFU ablation but has not responded adequately (i.e. \<50% volume reduction from baseline after 6 months),
  • a benign nodule without signs of malignancy (e.g, nonsuspicious clinical and US appearance, benign results at cytologic examination performed in the last 6 months, normal serum calcitonin level),
  • a nodule measuring on US greater than or equal to 10 mm in three orthogonal dimensions,
  • less than 30% of the targeted nodule comprising cystic area,
  • HIFU accessibility of the targeted nodule (distance between the skin and the anterior surface of the nodule less than 17 mm, with no interference of the collarbone with HIFU unit movements)
  • normal thyrotropin concentration and
  • absence of vocal cord immobility at laryngoscopy.

You may not qualify if:

  • head and/or neck disease preventing hyperextension of the neck,
  • history of thyroid cancer or other malignant tumors in the neck region,
  • history of neck irradiation,
  • intranodular macrocalcifications inducing a shadow substantial enough to preclude treatment with HIFU,
  • nodules next to the posterior margin of the thyroid lobe with anteroposterior diameter less than 15 mm,
  • pregnancy or lactation,
  • any contraindication related to intravenous moderate sedation in the first HIFU treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (10)

  • Gharib H, Papini E, Garber JR, Duick DS, Harrell RM, Hegedus L, Paschke R, Valcavi R, Vitti P; AACE/ACE/AME Task Force on Thyroid Nodules. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY, AND ASSOCIAZIONE MEDICI ENDOCRINOLOGI MEDICAL GUIDELINES FOR CLINICAL PRACTICE FOR THE DIAGNOSIS AND MANAGEMENT OF THYROID NODULES--2016 UPDATE. Endocr Pract. 2016 May;22(5):622-39. doi: 10.4158/EP161208.GL.

    PMID: 27167915BACKGROUND

  • Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.

    PMID: 26462967BACKGROUND

  • Durante C, Costante G, Lucisano G, Bruno R, Meringolo D, Paciaroni A, Puxeddu E, Torlontano M, Tumino S, Attard M, Lamartina L, Nicolucci A, Filetti S. The natural history of benign thyroid nodules. JAMA. 2015 Mar 3;313(9):926-35. doi: 10.1001/jama.2015.0956.

    PMID: 25734734BACKGROUND

  • Gharib H, Hegedus L, Pacella CM, Baek JH, Papini E. Clinical review: Nonsurgical, image-guided, minimally invasive therapy for thyroid nodules. J Clin Endocrinol Metab. 2013 Oct;98(10):3949-57. doi: 10.1210/jc.2013-1806. Epub 2013 Aug 16.

    PMID: 23956350BACKGROUND

  • Sung JY, Baek JH, Kim KS, Lee D, Yoo H, Kim JK, Park SH. Single-session treatment of benign cystic thyroid nodules with ethanol versus radiofrequency ablation: a prospective randomized study. Radiology. 2013 Oct;269(1):293-300. doi: 10.1148/radiol.13122134. Epub 2013 Apr 24.

    PMID: 23616630BACKGROUND

  • Korkusuz H, Sennert M, Fehre N, Happel C, Grunwald F. Local thyroid tissue ablation by high-intensity focused ultrasound: effects on thyroid function and first human feasibility study with hot and cold thyroid nodules. Int J Hyperthermia. 2014 Nov;30(7):480-5. doi: 10.3109/02656736.2014.962626. Epub 2014 Oct 14.

    PMID: 25313977BACKGROUND

  • Kovatcheva RD, Vlahov JD, Stoinov JI, Zaletel K. Benign Solid Thyroid Nodules: US-guided High-Intensity Focused Ultrasound Ablation-Initial Clinical Outcomes. Radiology. 2015 Aug;276(2):597-605. doi: 10.1148/radiol.15141492. Epub 2015 Mar 13.

    PMID: 25768327BACKGROUND

  • Lang BH, Woo YC, Wong CKH. High-Intensity Focused Ultrasound for Treatment of Symptomatic Benign Thyroid Nodules: A Prospective Study. Radiology. 2017 Sep;284(3):897-906. doi: 10.1148/radiol.2017161640. Epub 2017 Apr 18.

    PMID: 28419814BACKGROUND

  • Huh JY, Baek JH, Choi H, Kim JK, Lee JH. Symptomatic benign thyroid nodules: efficacy of additional radiofrequency ablation treatment session--prospective randomized study. Radiology. 2012 Jun;263(3):909-16. doi: 10.1148/radiol.12111300. Epub 2012 Mar 21.

    PMID: 22438360BACKGROUND

  • Jeong WK, Baek JH, Rhim H, Kim YS, Kwak MS, Jeong HJ, Lee D. Radiofrequency ablation of benign thyroid nodules: safety and imaging follow-up in 236 patients. Eur Radiol. 2008 Jun;18(6):1244-50. doi: 10.1007/s00330-008-0880-6. Epub 2008 Feb 20.

    PMID: 18286289BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Hung Hin, Brian Lang, MBBS (Hons)

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

October 27, 2017

First Posted

November 6, 2017

Study Start

July 1, 2017

Primary Completion

June 30, 2018

Study Completion

August 30, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

HK(1)