A Study to Evaluate Treatment of Papillary Thyroid Carcinoma with Radiofrequency Ablation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-005486
NCT ID: NCT04129411
Sponsor Protocol Number: 19-005486
About this study
The purpose of this study is to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult patients ≥ 18 years of age and ≤ 85 years of age.
- Nodule with Papillary thyroid carcinoma meeting the below criteria:
- Diagnosed by 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Marius Stan, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available