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High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

NCT ID: NCT01291498

Last Updated: 2017-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parathyroid Adenomas

Keywords

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Primary Parathyroid Adenomas

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HIFU Treatment

High Intensity Focused Ultrasound. This is not a comparative study

Group Type OTHER

High Intensity Focused Ultrasound

Intervention Type DEVICE

One or two HIFU sessions

Interventions

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High Intensity Focused Ultrasound

One or two HIFU sessions

Intervention Type DEVICE

Other Intervention Names

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TH-One HIFU device

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Theraclion

INDUSTRY

Sponsor Role collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Radu Mihai

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals NHS Trust

Locations

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John Radcliffe Hospital

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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HIFU-PT-2010-01

Identifier Type: -

Identifier Source: org_study_id