Trial Outcomes & Findings for Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation (NCT NCT04129411)

NCT ID: NCT04129411

Last Updated: 2025-05-20

Results Overview

Thyroid tumor volume shrinkage will be assessed by ultrasound and compared with pre-procedure volume (measure in mL)

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

24 months

Results posted on

2025-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	RFA Group RFA: Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
Overall Study STARTED	5
Overall Study Enrolled	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RFA Group n=5 Participants RFA: Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Papillary Thyroid Cancer (PTC) Location Right	3 Participants n=5 Participants
Papillary Thyroid Cancer (PTC) Location Left	2 Participants n=5 Participants
Papillary Thyroid Cancer (PTC) Location Isthmus	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Due to loss of follow up, some patients did not have data available at specific time interval.

Thyroid tumor volume shrinkage will be assessed by ultrasound and compared with pre-procedure volume (measure in mL)

Outcome measures

Outcome measures
Measure	RFA Group n=5 Participants RFA: Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
Changes in Thyroid Nodule Size Pre-RFA	0.241361 mL Standard Deviation 0.141814
Changes in Thyroid Nodule Size 3-6 months	0.954909 mL Standard Deviation 0.915872
Changes in Thyroid Nodule Size 7-12 months	0.422121 mL Standard Deviation 0.396916
Changes in Thyroid Nodule Size 13-18 months	0.104143 mL Standard Deviation 0.076919
Changes in Thyroid Nodule Size 19-24 months	0.040035 mL Standard Deviation 0.043296

SECONDARY outcome

Timeframe: Up to 24 months

Population: One patient reported localized neck erythema and pain that improved within a week with over-the-counter medication.

Assessed by number of participants that reported any pain related to RFA procedure

Outcome measures

Outcome measures
Measure	RFA Group n=5 Participants RFA: Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
Pain Related to RFA Procedure	1 Participants

SECONDARY outcome

Timeframe: 18 months

Assessed by the number of participants with cervical adenopathy (enlargement of lymph nodes in the neck area). Participants will be evaluated during follow-up visits.

Outcome measures

Outcome measures
Measure	RFA Group n=5 Participants RFA: Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
Development of Lymph Node Involvement	0 Participants

SECONDARY outcome

Timeframe: 18 months

Population: Considering the nature of the disease, distant metastasis was not specifically evaluated if no regional neck metastasis was detected on follow up. No patients developed neck lymphadenopathy.

Assessed by the number of participants with distant metastasis if regional neck metastasis is detected on follow up.

Outcome measures

Outcome measures
Measure	RFA Group n=5 Participants RFA: Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
Development of Distant Metastasis	0 Participants

SECONDARY outcome

Timeframe: Up to 24 months

Assessed by the number of participants who experienced infection, hematoma, bruising, or other complications at the RFA site.

Outcome measures

Outcome measures
Measure	RFA Group n=5 Participants RFA: Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
Safety of the RFA Procedure	0 Participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: Due to loss of follow up, some patients did not have data available at specific time interval.

Participants were tracked for thyroid status following radiofrequency ablation

Outcome measures

Outcome measures
Measure	RFA Group n=5 Participants RFA: Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
Change in Thyroid Status Thyroid Status, 3-6 months · Euthyroid	4 Participants
Change in Thyroid Status Thyroid Status, 3-6 months · Hypothyroid	0 Participants
Change in Thyroid Status Thyroid Status, 3-6 months · Hyperthyroid	1 Participants
Change in Thyroid Status Thyroid Status, 3-6 months · Unknown	0 Participants
Change in Thyroid Status Thyroid Status, 7-12 months · Euthyroid	5 Participants
Change in Thyroid Status Thyroid Status, 7-12 months · Hypothyroid	0 Participants
Change in Thyroid Status Thyroid Status, 7-12 months · Hyperthyroid	0 Participants
Change in Thyroid Status Thyroid Status, 7-12 months · Unknown	0 Participants
Change in Thyroid Status Thyroid Status, 13-18 months · Euthyroid	2 Participants
Change in Thyroid Status Thyroid Status, 13-18 months · Hypothyroid	0 Participants
Change in Thyroid Status Thyroid Status, 13-18 months · Hyperthyroid	0 Participants
Change in Thyroid Status Thyroid Status, 13-18 months · Unknown	1 Participants
Change in Thyroid Status Thyroid Status, 19-24 months · Euthyroid	2 Participants
Change in Thyroid Status Thyroid Status, 19-24 months · Hypothyroid	0 Participants
Change in Thyroid Status Thyroid Status, 19-24 months · Hyperthyroid	0 Participants
Change in Thyroid Status Thyroid Status, 19-24 months · Unknown	0 Participants

Adverse Events

RFA Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marius Stan

Mayo Clinic

Phone: 507-284-2463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place