High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

Parathyroid Adenomas Clinical Trial

Official title:

High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01291498
• Other study ID #: HIFU-PT-2010-01
• Status: Terminated
• Phase: N/A
• First received: February 7, 2011
• Last updated: November 7, 2017
• Start date: April 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Parathyroid Adenomas
• Parathyroid Neoplasms

Intervention

Device:
• High Intensity Focused Ultrasound
One or two HIFU sessions

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust	Theraclion

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eucalcaemia	Calcium in the blood is measured from venepuncture	12 months post-treatment
Secondary	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.
Secondary	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