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High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

18 Years
Open (Enrolling)
Parathyroid Adenomas

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Trial Information

High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

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.

Inclusion Criteria:


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

12 months post-treatment

Safety Issue:


Principal Investigator

Radu Mihai

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oxford University Hospitals NHS Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

January 2011

Completion Date:

October 2012

Related Keywords:

  • Parathyroid Adenomas
  • Primary Parathyroid Adenomas
  • Adenoma
  • Parathyroid Neoplasms