High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

Study Overview
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Brief Summary
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This study aims to determine whether HIFU treatment is a safe and effective alternative to an operation to remove all or part of the affected gland. The objective is to achieve biochemical cure (assessed by normal calcium level in the blood at six weeks, six months and one year after therapy) without affecting the patient's voice or ability to swallow.

Detailed Description
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Primary hyperparathyroidism is a common endocrine condition in which one or more of the four parathyroid glands in the neck releases too much parathyroid hormone (PTH). this leads to excess calcium in the blood and if untreated it can cause osteoporosis, kidney stone formation, deterioration of kidney function and disturbance in heart rhythm. Surgery to remove all or part of the affected gland(s) is expected to cure 95% of such patients. In current practice all such patients undergo localisation techniques using sestamibi scanning and neck ultrasonography to demonstrate the position of the enlarged/overactive parathyroid gland. These radiological tests are positive in some two thirds of patients, who can be operated through a minimally invasive procedure focused on the exact localisation pinpointed by the scans. This study uses a procedure that does not require a surgical incision. Precise imaging of the parathyroid glands allows the exact position of the tumour to be found from outside the body. A High Intensity Focused Ultrasound beam produces heat, but only in a small specific area. Exact positioning of the ultrasound beam targets the tumour cells and kills them without harming the surrounding healthy tissues.

Official Title
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High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

Conditions
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Parathyroid Adenomas

Intervention / Treatment
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* Device: High Intensity Focused Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary Hyperparathyroidism (PHPT) Moderate/severe hypercalcaemia (Ca>2.8mmol/L) Positive sestamibi scan demonstrating a cervical parathyroid adenoma Adenoma visible on ultrasound scan Exclusion Criteria: Large adenoma (>15mm) Deep adenoma (>20mm from skin surface Familial disease (eg members of MEN-1 families) Inability to complete questionnaires in English without making mistakes or needing help with translation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HIFU Treatment<br>High Intensity Focused Ultrasound. This is not a comparative study | Device: High Intensity Focused Ultrasound<br>* One or two HIFU sessions<br>* Other names: TH-One HIFU device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eucalcaemia | Calcium in the blood is measured from venepuncture | 12 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eucalcaemia | Ca in plasma | Six weeks post-treatment.Six month data were also intended to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment. | 
| Voice Morbidity | Voice Handicap Index. 30 questions rated on a five point scale from 'never' to 'always' and an overall score from 1 'normal' to 10 'severely impaired' | Up to one year post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Parathyroid Adenomas