NCT07475780 · M.D. Anderson Cancer Center
Radiofrequency Ablation For Recurrent Parathyroid Carcinoma
What this study is about
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.
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult patients with recurrent parathyroid carcinoma that was previously resected and persistent or recurrent hypercalciemia. Patients are not surgical candidates or strongly desire nonsurgical intervention. Eligibility for enrollment will be based upon meeting inclusion and
Exclusion criteria
- as detailed in section 4.1 and 4.2. The study will include 20 eligible patients or lesions. Utmost care will be taken to minimize risk to patients through careful selection of patients and scheduled assessments (Table 1). Patients will be recruited through the Endocrine, Endocrine surgery, Head and Neck Surgery Clinics, as well as Neuro-Interventional Radiology Ultrasound. All patients who meet the inclusion and exclusion criteria and agree to participate in the study will be consented and then enrolled into the study. No other criteria, apart from the eligibility criteria detailed below, will be used for subject selection. We anticipate enrolling approximately 1 patient every 2 months (0.5 patients/month), for a total accrual period of up to 40 months to reach the planned sample size of 20 patients. Each participant will be followed for 12 months after RFA, so the total study duration is estimated at approximately 52 months from first patient enrollment to last patient follow-up. Candidates for this study must meet all of the following inclusion criteria:
- 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.
- Presence of local recurrence or implant in the neck visible on ultrasound.
- Distant oligometastasis visible on ultrasound.
- Solid nodule without macrocalcification or internal cystic degeneration
- Patient who is off of Cinacalcet
- Entirety of the selected nodule is visible on ultrasound without significant extension posterior to trachea or mediastinal component (ie Type A, E, or high F).
- Selected nodule is amenable to medial or lateral approach.
- Normal complete blood count, blood coagulation.
- Patient agrees to participate in the clinical study and to complete all required visits and evaluations.
- Negative serum or urine pregnancy test for females of childbearing potential at baseline pre-procedure evaluation. Exclusion Criteria: Candidates will be ineligible for enrollment in the study if any of the following conditions apply:
- Patients with cardiac arrhythmia and/or implanted cardiac device
- Surgically naïve parathyroid lesions, parathyroid adenoma or atypical parathyroid tumor.
- Allergies to medications for anesthesia.
- Cystic nodules (\< 70% solid components)
- Calcified nodules
- Targeted nodule within 0.5 cm from the major vessels, vagus nerve, brachial plexus, and recurrent laryngeal nerve.
- Patients with contralateral vocal cord paralysis.
- Uncorrectable coagulopathy with PTT\>1.5 X ULN or INR \>1.5 or platelet count \<100,000 per mm3
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations