Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
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|ClinicalTrials.gov Identifier: NCT04129411|
Recruitment Status : Not yet recruiting
First Posted : October 16, 2019
Last Update Posted : December 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Papillary Thyroid Cancer Papillary Thyroid Microcarcinoma||Device: RFA||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label single interventional series|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study for the Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation|
|Estimated Study Start Date :||January 15, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||June 30, 2022|
|Experimental: RFA Group||
Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
- Changes in thyroid nodule size (overall volume measured in percentage) [ Time Frame: 18 months ]Thyroid tumor volume shrinkage in percentage will be assessed by ultrasound and compared with pre-procedure volume.
- Pain related to RFA procedure [ Time Frame: 1-2 months ]McGill Pain Questionnaire (Pain intensity scale: 0 = none, 1 = mild, 2 = moderate or 3 = severe)
- Development of lymph node involvement [ Time Frame: 18 months ]Cervical adenopathy
- Development of distant metastasis [ Time Frame: 18 months ]Distant metastatic sites
- Safety of the RFA procedure [ Time Frame: 1-2 months ]Evaluation of site of RFA for local complication and asses pain with McGill Pain Questionnaire (Pain intensity scale: 0 = none, 1 = mild, 2 = moderate or 3 = severe)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129411
|Contact: Marius Stan, MDemail@example.com|
|Contact: Vishakantha Murthy, PhD., MBA||507-255-8112||Murthy.Vishakantha@mayo.edu|
|Principal Investigator:||Marius Stan, MD||Mayo Clinic|