Radiofrequency Ablation For Recurrent Parathyroid Carcinoma
ConditionRecurrent Parathyroid Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
The study will be an effectiveness study. The study will include enrollment of a total of 20 patients with at least one PC lesion for ultrasound guided RFA to PC recurrence in the neck to assess the effectiveness in reducing patient's hypercalcemia. Patients will have surgically proven PC from prior parathyroidectomy and suspicious PC visible on ultrasound and request for treatment for uncontrolled hypercalcemia (Figure 1).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patient is older than 18 years, is not a surgical candidate or refuses to have surgery.
Patient is medically fit to undergo local anesthesia with or without conscious sedation.
Patient is able to understand and give consent to participation in the study.
Confirmed parathyroid carcinoma by prior surgery and histopathology.
Trial design
Design model
Single group
Treatments tested in this trial
Ultrasound-guided RFA
DeviceParticipants will be positioned supine with full neck extension. Preprocedural intraoperative PTH will be drawn. Radiofrequency ablation (RFA) will be performed on one or up to 5 nodules on ipsilateral side per participant.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment with Ultrasound-guide RFAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov