Papillary Thyroid Cancer, Papillary Thyroid Microcarcinoma
Conditions
Keywords
RFA, Radiofrequency, Thyroid Cancer, Ablation techniques, Ultrasonography
Brief summary
Investigators intend to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.
Detailed description
Investigators plan to identify patients with small papillary thyroid carcinoma and subject such patients to radiofrequency ablation (RFA) therapy. Following RFA procedure patients will be monitored to study the changes in primary tumor volume, development of lymph node involvement, development of distant metastasis and changes in serum thyroid hormone levels. Investigators will also assess the stability of these changes (need for repeat therapy) and the safety of the RFA procedure.
Interventions
DEVICERFA
Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label single interventional series
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Are adults * Nodule with Papillary thyroid carcinoma meeting the below criteria: * Diagnosed by fine needle aspiration (FNA) cytology. * Size \< 1.5 cm * Non-surgical therapy is considered acceptable by the treating physician * Radiology evaluation deems the lesion amenable to RFA therapy with minimal risk of complication
Exclusion criteria
* Clinical evidence for a multifocal papillary thyroid malignancy * Clinical evidence for local or distant metastatic disease * Pregnancy * Vocal cord paralysis on contralateral side * Coagulopathy or patients on anticoagulation therapy * Patients with prior neck surgery or neck radiation * Patients with neck anatomy that precludes easy access by RFA * Patients with comorbidities deemed too high of a risk for general anesthesia * Treatment with another investigational drug or intervention (within 6 weeks of planned RFA). * Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Thyroid Nodule Size | 24 months | Thyroid tumor volume shrinkage will be assessed by ultrasound and compared with pre-procedure volume (measure in mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Related to RFA Procedure | Up to 24 months | Assessed by number of participants that reported any pain related to RFA procedure |
| Development of Lymph Node Involvement | 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. |
| Development of Distant Metastasis | 18 months | Assessed by the number of participants with distant metastasis if regional neck metastasis is detected on follow up. |
| Safety of the RFA Procedure | Up to 24 months | Assessed by the number of participants who experienced infection, hematoma, bruising, or other complications at the RFA site. |
| Change in Thyroid Status | Up to 24 months | Participants were tracked for thyroid status following radiofrequency ablation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RFA Group RFA: Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | RFA Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Papillary Thyroid Cancer (PTC) Location Isthmus | 0 Participants |
| Papillary Thyroid Cancer (PTC) Location Left | 2 Participants |
| Papillary Thyroid Cancer (PTC) Location Right | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Changes in Thyroid Nodule Size
Thyroid tumor volume shrinkage will be assessed by ultrasound and compared with pre-procedure volume (measure in mL)
Time frame: 24 months
Population: Due to loss of follow up, some patients did not have data available at specific time interval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RFA Group | Changes in Thyroid Nodule Size | Pre-RFA | 0.241361 mL | Standard Deviation 0.141814 |
| RFA Group | Changes in Thyroid Nodule Size | 3-6 months | 0.954909 mL | Standard Deviation 0.915872 |
| RFA Group | Changes in Thyroid Nodule Size | 7-12 months | 0.422121 mL | Standard Deviation 0.396916 |
| RFA Group | Changes in Thyroid Nodule Size | 13-18 months | 0.104143 mL | Standard Deviation 0.076919 |
| RFA Group | Changes in Thyroid Nodule Size | 19-24 months | 0.040035 mL | Standard Deviation 0.043296 |
Secondary
Change in Thyroid Status
Participants were tracked for thyroid status following radiofrequency ablation
Time frame: Up to 24 months
Population: Due to loss of follow up, some patients did not have data available at specific time interval.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| RFA Group | Change in Thyroid Status | Thyroid Status, 3-6 months | Euthyroid | 4 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 3-6 months | Hypothyroid | 0 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 3-6 months | Hyperthyroid | 1 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 3-6 months | Unknown | 0 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 7-12 months | Euthyroid | 5 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 7-12 months | Hypothyroid | 0 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 7-12 months | Hyperthyroid | 0 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 7-12 months | Unknown | 0 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 13-18 months | Euthyroid | 2 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 13-18 months | Hypothyroid | 0 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 13-18 months | Hyperthyroid | 0 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 13-18 months | Unknown | 1 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 19-24 months | Euthyroid | 2 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 19-24 months | Hypothyroid | 0 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 19-24 months | Hyperthyroid | 0 Participants |
| RFA Group | Change in Thyroid Status | Thyroid Status, 19-24 months | Unknown | 0 Participants |
Secondary
Development of Distant Metastasis
Assessed by the number of participants with distant metastasis if regional neck metastasis is detected on follow up.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFA Group | Development of Distant Metastasis | 0 Participants |
Secondary
Development of Lymph Node Involvement
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.
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFA Group | Development of Lymph Node Involvement | 0 Participants |
Secondary
Pain Related to RFA Procedure
Assessed by number of participants that reported any pain related to RFA procedure
Time frame: Up to 24 months
Population: One patient reported localized neck erythema and pain that improved within a week with over-the-counter medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFA Group | Pain Related to RFA Procedure | 1 Participants |
Secondary
Safety of the RFA Procedure
Assessed by the number of participants who experienced infection, hematoma, bruising, or other complications at the RFA site.
Time frame: Up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RFA Group | Safety of the RFA Procedure | 0 Participants |