High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

November 7, 2017 updated by: Oxford University Hospitals NHS Trust
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HIFU Treatment
High Intensity Focused Ultrasound. This is not a comparative study
Device: High Intensity Focused Ultrasound
One or two HIFU sessions
Other Names:
  • TH-One HIFU device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eucalcaemia
Time Frame: 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.
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
Time Frame: Up to one year post-treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Hospitals NHS Trust

Collaborators

Theraclion

Investigators

  • Principal Investigator: Radu Mihai, Oxford University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (Estimate)

February 8, 2011

Study Record Updates

Last Update Posted (Actual)

December 18, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIFU-PT-2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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