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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-01892 | Other Identifier | NCI-CTRP Clinical Registry |
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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).
Primary Objective:
• Evaluate treatment response of RFA of recurrent PC by means of longitudinal monitoring patient serum calcium level and PTH.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Ultrasound-guide RFA | Experimental | Participants treatment will be administered on an outpatient basis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided RFA | Device | Participants 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion; an average of 1 year |
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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:
Exclusion Criteria:
Candidates will be ineligible for enrollment in the study if any of the following conditions apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thinh Vu, MD | Contact | (281) 415-2061 | thinh.vu@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Thinh Vu, MD | UT MD Anderson | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D010282 | Parathyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| D004700 |
| Endocrine System Diseases |
| D010279 | Parathyroid Diseases |