Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
Primary Purpose
Papillary Thyroid Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Papillary Thyroid Cancer
Eligibility Criteria
Inclusion Criteria:
- All patients regardless of sex or race between the ages 18-100 with biopsy proven PTMC with a Bethesda V or VI pathology or indeterminate cytology on fine-needle aspiration cytology (FNAC) who are recommended for treatment (Bethesda III/IV).
- Solitary thyroid nodule <20mm in maximal dimension.
- No sonographic evidence of extrathyroidal invasion, lymph node metastases, or distant metastases.
- There must be at least 1 mm of normal tissue as a margin, without sonographic evidence of contact with the capsule.
Exclusion Criteria:
- Patients with other histological types of thyroid malignancy other than papillary thyroid cancer such as medullary carcinoma, Proto-oncogene serine/threonine kinase (BRAF) or Telomerase reverse transcriptase (TERT) mutations
- Clinically apparent multicentricity
- Lesions larger than 20 mm in maximum diameter.
- Recurrent laryngeal nerve palsy.
- Extension of nodule to posterior thyroid capsule.
- Ultrasound or other imaging studies revealing cervical lymph node involvement or distant metastases.
- Pregnancy.
- Pacemaker.
- Previous RFA.
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiofrequency Ablation
Arm Description
Patients will receive RFA as a one-time intervention, with a possible second treatment after 6 months if adequate resolution is not noted on ultrasound.
Outcomes
Primary Outcome Measures
Percentage change in nodule volume
This will assess the percentage change in nodule volume (cubic millimeters).
Secondary Outcome Measures
Percentage change in nodule volume
This will assess the percentage change in nodule volume (cubic millimeters).
Percentage change in nodule volume
This will assess the percentage change in nodule volume (cubic millimeters).
Change in voice related quality of life as assessed by the VHI-10
Change from baseline in Voice Handicap index (VHI-10) score. Score ranges from 0-40. Higher score indicates worse symptoms.
Change in voice related quality of life as assessed by the VHI-10
Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
Change in voice related quality of life as assessed by the VHI-10
Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
Scar cosmesis score
Average score on Scar cosmesis assessment and rating (SCAR) scale. Score ranges from 0-15. Higher score indicates worse scar.
Scar cosmesis score
Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.
Scar cosmesis score
Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.
Change in eating assessment score as assessed by the EAT-10
Change from baseline on Eating assessment tool (EAT-10) score. Score ranges from 0-40. Higher score indicates worse symptoms.
Change in eating assessment score as assessed by the EAT-10
Change from baseline on EAT-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
Change in eating assessment score as assessed by the EAT-10
Change from baseline on EAT-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
Change in overall quality of life assessed by the PROMIS score
Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS)-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.
Change in overall quality of life assessed by the PROMIS score
Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.
Change in overall quality of life assessed by the PROMIS score
Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.
Number of complications
Counts of skin burn, hematoma and vocal cord palsy.
Full Information
NCT ID
NCT05132205
First Posted
November 10, 2021
Last Updated
December 5, 2022
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT05132205
Brief Title
Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
Official Title
Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
September 28, 2024 (Anticipated)
Study Completion Date
September 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Traditionally, surgery has been the standard recommendation for treating papillary thyroid cancer. The risk of surgery including permanent hoarseness, permanent hypocalcemia, a mid-cervical scar, and the potential for permanent hypothyroidism may be unacceptable for some patients, especially with low risk papillary thyroid carcinoma. The recent American Thyroid Association guidelines have proposed the option of active surveillance with low risk papillary thyroid cancer less than 210 mm. However, most patients find observation anxiety provoking knowing of having cancer. Radiofrequency ablation (RFA) of small low risk papillary thyroid cancer is a promising therapeutic modality for these patients that reduces the risks associated with surgery and the anxiety of taking a watchful approach. However, this technique has not been validated in the North American population.
The investigators aim to describe the investigators' initial experience with RFA of low risk papillary thyroid microcarcinoma (PTMC) compared to active surveillance (AS) done by Head and Neck Endocrine surgeons at Johns Hopkins Medical Institute.
Primary objective:
To evaluate the safety, efficacy and oncological outcomes of the procedure.
Secondary objective:
To determine the patient functional outcomes in comparison to the observational control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency Ablation
Arm Type
Experimental
Arm Description
Patients will receive RFA as a one-time intervention, with a possible second treatment after 6 months if adequate resolution is not noted on ultrasound.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Ablation
Intervention Description
Radiofrequency Ablation using RFMedical device.
Primary Outcome Measure Information:
Title
Percentage change in nodule volume
Description
This will assess the percentage change in nodule volume (cubic millimeters).
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Percentage change in nodule volume
Description
This will assess the percentage change in nodule volume (cubic millimeters).
Time Frame
Baseline and 6 months
Title
Percentage change in nodule volume
Description
This will assess the percentage change in nodule volume (cubic millimeters).
Time Frame
Baseline and 24 months
Title
Change in voice related quality of life as assessed by the VHI-10
Description
Change from baseline in Voice Handicap index (VHI-10) score. Score ranges from 0-40. Higher score indicates worse symptoms.
Time Frame
Baseline and 6 months
Title
Change in voice related quality of life as assessed by the VHI-10
Description
Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
Time Frame
Baseline and 12 months
Title
Change in voice related quality of life as assessed by the VHI-10
Description
Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
Time Frame
Baseline and 24 months
Title
Scar cosmesis score
Description
Average score on Scar cosmesis assessment and rating (SCAR) scale. Score ranges from 0-15. Higher score indicates worse scar.
Time Frame
6 months
Title
Scar cosmesis score
Description
Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.
Time Frame
12 months
Title
Scar cosmesis score
Description
Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.
Time Frame
24 months
Title
Change in eating assessment score as assessed by the EAT-10
Description
Change from baseline on Eating assessment tool (EAT-10) score. Score ranges from 0-40. Higher score indicates worse symptoms.
Time Frame
Baseline and 6 months
Title
Change in eating assessment score as assessed by the EAT-10
Description
Change from baseline on EAT-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
Time Frame
Baseline and 12 months
Title
Change in eating assessment score as assessed by the EAT-10
Description
Change from baseline on EAT-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.
Time Frame
Baseline and 24 months
Title
Change in overall quality of life assessed by the PROMIS score
Description
Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS)-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.
Time Frame
Baseline and 6 months
Title
Change in overall quality of life assessed by the PROMIS score
Description
Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.
Time Frame
Baseline and 12 months
Title
Change in overall quality of life assessed by the PROMIS score
Description
Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.
Time Frame
Baseline and 24 months
Title
Number of complications
Description
Counts of skin burn, hematoma and vocal cord palsy.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients regardless of sex or race between the ages 18-100 with biopsy proven PTMC with a Bethesda V or VI pathology or indeterminate cytology on fine-needle aspiration cytology (FNAC) who are recommended for treatment (Bethesda III/IV).
Solitary thyroid nodule <20mm in maximal dimension.
No sonographic evidence of extrathyroidal invasion, lymph node metastases, or distant metastases.
There must be at least 1 mm of normal tissue as a margin, without sonographic evidence of contact with the capsule.
Exclusion Criteria:
Patients with other histological types of thyroid malignancy other than papillary thyroid cancer such as medullary carcinoma, Proto-oncogene serine/threonine kinase (BRAF) or Telomerase reverse transcriptase (TERT) mutations
Clinically apparent multicentricity
Lesions larger than 20 mm in maximum diameter.
Recurrent laryngeal nerve palsy.
Extension of nodule to posterior thyroid capsule.
Ultrasound or other imaging studies revealing cervical lymph node involvement or distant metastases.
Pregnancy.
Pacemaker.
Previous RFA.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathon Russell, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21278
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
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