A Trial Comparing USG-HIFU vs AS in Management of Low-risk PTMC

NCT03327636 | Suspended DMC

• 1 other identifier: UW 17-175
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Papillary thyroid microcarcinoma (PTMC) is a common tumor in Hong Kong. Early immediate surgery has traditionally been recommended. However, given its excellent prognosis, some have recommended Active Surveillance (AS) as an alternative. AS involves monitoring the patients who have PTMC until the tumor progresses. On the other hand, a new technology of ablation has been developing to be an alternative treatment for thyroid nodules comparing with traditional surgery, named High intensity focused ultrasound (HIFU). In our previous study, HIFU is proved in shrinking the size of target site by 6 months gradually and effectively. The investigator hypothesize that HIFU is an effective treatment for PTMC. Compared to AS, HIFU may be a better option as it not only halts disease progression but also has a longer progression-free survival, longer time to tumor progression and is less likely to harbor active disease.

Conditions

Papillary Thyroid Microcarcinoma

Keywords

Papillary Thyroid Microcarcinoma; High intensity focused ultrasound; Active surveillance

Outcome Measures

Primary Outcomes (1)

• The proportion of tumors exhibiting disease progression

  To compare the proportion of patients with PTMC exhibiting signs of progression between HIFU and AS group at 24 months

  24 months

Secondary Outcomes (6)

• Median duration of progression-free survival

  24 months

• Change in tumor volume

  24 months

• Proportion of patients with active disease

  24 months

• Proportion of patients undergoing planned and unplanned thyroidectomy

  24 months

• Health related quality of life (HRQOL)

  24 months

Study Arms (2)

High Intensity Focused Ultrasound

EXPERIMENTAL

Apply the machine 'Echopulse' with High Intensity Focused Ultrasound to treat the papillary thyroid microcarcinoma.

Device: Echopulse

Active surveillance

NO INTERVENTION

The participants will be monitored by the doctors actively, like more frequent in follow-up to observe their current situation.

Interventions

Echopulse DEVICE

This is a machine to apply high intensity focused ultrasound to ablation the target zone. In this study, we would apply it to the papillary thyroid microcarcinoma.

Also known as: High Intensity Focused Ultrasound (HIFU)

High Intensity Focused Ultrasound

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a thyroid nodule ≤10mm in the largest dimension that is confirmed on FNAC to be PTC (Bethesda class VI cytology) or suspicious of PTC (Bethesda V cytology). For the latter, the nodule needs to have an additional suspicious sonographic feature (i.e. marked hypoechogenicity, irregular margins, height-to-wide ratio \>1 and intravascular microcalcifications);
• Have not expressed a strong desire for immediate surgery after PTMC has been confirmed.

You may not qualify if:

• Age ≤ 18 or ≥ 75 years old;
• Have another thyroid nodule that is either indeterminate or malignant on FNAC;
• Have concomitant hypo- or hyperthyroidism (i.e. thyroid stimulating hormone (TSH) and/or free thyroxine levels outside the normal ranges)
• Have sonographic evidence of chronic lymphocytic thyroiditis (because this generally makes it difficult to assess and reassess tumor size accurately on USG alone)
• Have a tumor considered not suitable for AS. This includes a PTMC with extrathyroidal extension, concomitant nodal or distant metastasis or a PTMC located within 3mm from trachea-esophageal groove or recurrent laryngeal nerve.
• Have a condition considered not suitable for HIFU treatment (pregnancy, history of neck irradiation, known contralateral vocal cord palsy, a tumor with coarse, macroscopic intranodular calcifications or located outside the treatable depth of 5-30 mm from the skin, family history of non-medullary thyroid carcinoma and medical conditions precluding intravenous sedation).

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (16)

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  PMID: 24001104 BACKGROUND

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• National Cancer Comprehensive Network (NCCN Guidelines) 2015 Thyroid carcinoma. Version 2. 2015. Available: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp [Accessed on 16th February 2016]

  BACKGROUND

• Perros P, Boelaert K, Colley S, Evans C, Evans RM, Gerrard Ba G, Gilbert J, Harrison B, Johnson SJ, Giles TE, Moss L, Lewington V, Newbold K, Taylor J, Thakker RV, Watkinson J, Williams GR; British Thyroid Association. Guidelines for the management of thyroid cancer. Clin Endocrinol (Oxf). 2014 Jul;81 Suppl 1:1-122. doi: 10.1111/cen.12515. No abstract available.

  PMID: 24989897 BACKGROUND

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  PMID: 16858194 BACKGROUND

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MeSH Terms

Conditions

Papillary Thyroid Microcarcinoma

Study Officials

• Hung Hin, Brian Lang, MBBS (Hons)

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Participants will be arranged into either HIFU group or AS group randomly

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 31, 2017
• Study Start: October 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

HK (1)