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Investigators intend to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RFA | Device | Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Thyroid Nodule Size | Thyroid tumor volume shrinkage will be assessed by ultrasound and compared with pre-procedure volume (measure in mL) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Related to RFA Procedure | Assessed by number of participants that reported any pain related to RFA procedure | Up to 24 months |
| 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. |
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Inclusion Criteria:
Are adults
Nodule with Papillary thyroid carcinoma meeting the below criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marius Stan, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | RFA Group | RFA: Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adults (18 years or older) who had Bethesda V or VI cytologic confirmation of a single-lesion small PTC (measuring less than 2 cm in largest diameter, without lymph node metastasis on neck ultrasonography) who refused standard therapy (surgical procedure or active surveillance) and underwent radiofrequency ablation. The electronic medical records of the patients were reviewed, and those without available follow-up data were excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | RFA Group | RFA: Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Thyroid Nodule Size | Thyroid tumor volume shrinkage will be assessed by ultrasound and compared with pre-procedure volume (measure in mL) | Due to loss of follow up, some patients did not have data available at specific time interval. | Posted | Mean | Standard Deviation | mL | 24 months |
|
|
24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RFA Group | RFA: Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer. No adverse events were reported by participants. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marius Stan | Mayo Clinic | 507-284-2463 | stan.marius@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2019 | Mar 18, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2020 | Mar 18, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000077273 | Thyroid Cancer, Papillary |
| C563277 | Papillary Thyroid Microcarcinoma |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D000231 | Adenocarcinoma, Papillary |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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Open label single interventional series
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| 18 months |
| Development of Distant Metastasis | Assessed by the number of participants with distant metastasis if regional neck metastasis is detected on follow up. | 18 months |
| Safety of the RFA Procedure | Assessed by the number of participants who experienced infection, hematoma, bruising, or other complications at the RFA site. | Up to 24 months |
| Change in Thyroid Status | Participants were tracked for thyroid status following radiofrequency ablation | Up to 24 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Papillary Thyroid Cancer (PTC) Location | Count of Participants | Participants |
|
|
| Secondary | Pain Related to RFA Procedure | Assessed by number of participants that reported any pain related to RFA procedure | One patient reported localized neck erythema and pain that improved within a week with over-the-counter medication. | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 18 months |
|
|
|
| Secondary | Development of Distant Metastasis | Assessed by the number of participants with distant metastasis if regional neck metastasis is detected on follow up. | 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. | Posted | Count of Participants | Participants | 18 months |
|
|
|
| Secondary | Safety of the RFA Procedure | Assessed by the number of participants who experienced infection, hematoma, bruising, or other complications at the RFA site. | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| Secondary | Change in Thyroid Status | Participants were tracked for thyroid status following radiofrequency ablation | Due to loss of follow up, some patients did not have data available at specific time interval. | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| Hyperthyroid |
|
| Unknown |
|
| Thyroid Status, 7-12 months |
|
|
| Thyroid Status, 13-18 months |
|
|
| Thyroid Status, 19-24 months |
|
|