Recurrent Parathyroid CarcinomaNCT07475780
Radiofrequency Ablation For Recurrent Parathyroid Carcinoma
A study testing Ultrasound-guided RFA in people with Recurrent Parathyroid Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Parathyroid Carcinoma
- What is being tested?
- Ultrasound-guided RFA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2026to 30 Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- Pregnancy
- Allergies to medications for anesthesia.
- Cystic nodules (< 70% solid components)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT MD Anderson
Houston, Texas, 77030
Thinh Vu, MD, 281-415-2061, thinh.vu@mdanderson.org
Thinh Vu, MD
About this study
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).
Read the detailed description
Primary Objective:
- Evaluate treatment response of RFA of recurrent PC by means of longitudinal monitoring patient serum calcium level and PTH.
Secondary Objectives:
- Evaluate the sonographic features of the recurrent PC induced by RFA.
- Evaluation of procedure-related complications
- Disease free survival until recurrence of hypercalcemia
- Conditions
- Recurrent Parathyroid Carcinoma
- Being tested
- Ultrasound-guided RFA
- Medical subject headings
- Parathyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided RFADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Ultrasound-guide RFA | Experimental | Participants treatment will be administered on an outpatient basis. Receives: Device: Ultrasound-guided RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start9 Apr 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Parathyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thinh Vu, MD, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475780
- Sponsor's protocol ID
- 2025-1470
- Other IDs
- NCI-2026-01892
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation For Recurrent Parathyroid Carcinoma
- ClinicalTrials.gov ID
- NCT07475780
- Acronym / sponsor ID
- 2025-1470
- Conditions
- Recurrent Parathyroid Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2031 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Primary Objective:
- Evaluate treatment response of RFA of recurrent PC by means of longitudinal monitoring patient serum calcium level and PTH.
Secondary Objectives:
- Evaluate the sonographic features of the recurrent PC induced by RFA.
- Evaluation of procedure-related complications
- Disease free survival until recurrence of hypercalcemia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Ultrasound-guide RFA | Experimental | Device: Ultrasound-guided RFAParticipants treatment will be administered on an outpatient basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- 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.
Key exclusion criteria (10 listed)
- 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.
- Pregnancy
- Allergies to medications for anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided RFAParticipants 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. | Device | Treatment with Ultrasound-guide RFA |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thinh Vu, MD principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided RFA in people with Recurrent Parathyroid Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thinh Vu, MD ((281) 415-2061, thinh.vu@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.