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High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01291498
Recruitment Status : Terminated (The manufacturer is not currently supporting research in this indication.)
First Posted : February 8, 2011
Results First Posted : June 25, 2014
Last Update Posted : December 18, 2017
Information provided by (Responsible Party):
Oxford University Hospitals NHS Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Parathyroid Adenomas Device: High Intensity Focused Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma
Study Start Date : April 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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

Primary Outcome Measures :
  1. Eucalcaemia [ Time Frame: 12 months post-treatment ]
    Calcium in the blood is measured from venepuncture

Secondary Outcome Measures :
  1. 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

  2. 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'

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01291498

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United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
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Principal Investigator: Radu Mihai Oxford University Hospitals NHS Trust
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Responsible Party: Oxford University Hospitals NHS Trust Identifier: NCT01291498    
Other Study ID Numbers: HIFU-PT-2010-01
First Posted: February 8, 2011    Key Record Dates
Results First Posted: June 25, 2014
Last Update Posted: December 18, 2017
Last Verified: July 2014
Keywords provided by Oxford University Hospitals NHS Trust:
Primary Parathyroid Adenomas
Additional relevant MeSH terms:
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Parathyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Parathyroid Diseases