Papillary Thyroid CancerNCT05132205
Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
A study testing Radiofrequency Ablation in people with Papillary Thyroid Cancer, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Papillary Thyroid Cancer
- What is being tested?
- Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2021to 19 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnancy.
- Pacemaker.
- Previous RFA.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Papillary Thyroid Cancer
- Being tested
- Radiofrequency Ablation
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency AblationProcedure or surgery
Radiofrequency Ablation using RFMedical device.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation | Experimental | 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. Receives: Procedure: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in nodule volume
This will assess the percentage change in nodule volume (cubic millimeters).
Measured: Baseline and 12 months
Secondary outcomes (15)
Percentage change in nodule volume
This will assess the percentage change in nodule volume (cubic millimeters).
Measured: Baseline and 6 months
Percentage change in nodule volume
This will assess the percentage change in nodule volume (cubic millimeters).
Measured: Baseline and 24 months
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 12 months
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.
Measured: Baseline and 24 months
Scar cosmesis score
Average score on Scar cosmesis assessment and rating (SCAR) scale. Score ranges from 0-15. Higher score indicates worse scar.
Measured: 6 months
Scar cosmesis score
Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.
Measured: 12 months
Scar cosmesis score
Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.
Measured: 24 months
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 12 months
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.
Measured: Baseline and 24 months
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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 12 months
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.
Measured: Baseline and 24 months
Number of complications
Counts of skin burn, hematoma and vocal cord palsy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start17 Dec 2021
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- RF Medical Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Jonathon Russell, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132205
- Sponsor's protocol ID
- IRB00236242
- Status last verified
- Jan 2025
- First submitted
- 10 Nov 2021
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation of Papillary Thyroid Microcarcinoma
- ClinicalTrials.gov ID
- NCT05132205
- Acronym / sponsor ID
- IRB00236242
- Conditions
- Papillary Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- RF Medical Co., Ltd
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation | Experimental | Procedure: Radiofrequency AblationPatients will receive RFA as a one-time intervention, with a possible second treatment after 6 months if adequate resolution is not noted on ultrasound. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency AblationRadiofrequency Ablation using RFMedical device. | Procedure or surgery | Radiofrequency Ablation |
Primary outcome
Percentage change in nodule volume
Time frame: Baseline and 12 months
This will assess the percentage change in nodule volume (cubic millimeters).
15 secondary outcomes
Percentage change in nodule volume
Time frame: Baseline and 6 months
Percentage change in nodule volume
Time frame: Baseline and 24 months
Change in voice related quality of life as assessed by the VHI-10
Time frame: Baseline and 6 months
Change in voice related quality of life as assessed by the VHI-10
Time frame: Baseline and 12 months
Change in voice related quality of life as assessed by the VHI-10
Time frame: Baseline and 24 months
Scar cosmesis score
Time frame: 6 months
Scar cosmesis score
Time frame: 12 months
Scar cosmesis score
Time frame: 24 months
Change in eating assessment score as assessed by the EAT-10
Time frame: Baseline and 6 months
Change in eating assessment score as assessed by the EAT-10
Time frame: Baseline and 12 months
Change in eating assessment score as assessed by the EAT-10
Time frame: Baseline and 24 months
Change in overall quality of life assessed by the PROMIS score
Time frame: Baseline and 6 months
Change in overall quality of life assessed by the PROMIS score
Time frame: Baseline and 12 months
Change in overall quality of life assessed by the PROMIS score
Time frame: Baseline and 24 months
Number of complications
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Papillary Thyroid Cancer
Recruiting
Active Surveillance of Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma
RecruitingObservational study
Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
Papillary Thyroid Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Differentiated Thyroid Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathon Russell, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation in people with Papillary Thyroid Cancer, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in nodule volume (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.