Pulsed Field Ablation, Thyroid Nodules
Conditions
Brief summary
To observe the outcomes of nsPFA therapy to treat benign thyroid nodules.
Detailed description
Primary Objectives • To evaluate the thyroid nodule volume changes over time in participants undergoing nsPFA as part of routine clinical care Secondary Objectives * To determine changes in health-related quality of life changes following ultrasound-guided nsPFA * To evaluate the ultrasound features of thyroid nodules over time following ultrasound-guided nsPFA. * To assess the incidence and nature of complications following ultrasound-guided nsPFA, categorized into Minor and Major complications.
Interventions
OTHERQuestionnaire
patient-reported outcomes questionnaire
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria * Scheduled to undergo ultrasound guided nsPFA as standard of care * Age 18 to 80 years. * Capable of providing independent consent. * Presence of biopsy-confirmed benign thyroid nodule , defined as one of the following: * Benign FNA X 2 or * Benign US guided FNA X 1 + benign thyroid nodule ultrasound appearance (TI-RADS 2) or * Benign FNA X 1 and radiographic/laboratory evidence of functional nature * Nodule measuring \>2cm in greatest dimension * Presence of compressive symptoms reasonably attributable to thyroid nodule (i.e. pressure sensation, dysphagia, dysphonia, respiratory distress) * No abnormal cervical lymph nodes during screening visit .
Exclusion criteria
* Age \<18 * Patients considered unsuitable for nsPFA by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality-of-life Questionnaire | Through study completion; an average of 1 year |
Countries
United States
Contacts
CONTACTVictoria E Banuchi, MD
PRINCIPAL_INVESTIGATORVictoria E Banuchi, MD
M.D. Anderson Cancer Center
Outcome results
None listed