High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

NHS Trust

Status

Terminated

Conditions

Parathyroid Adenomas

Treatments

Device: High Intensity Focused Ultrasound

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01291498

HIFU-PT-2010-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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