Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Adenoma

Hyperparathyroidism

Hyperparathyroidism, Primary

Parathyroid Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Endocrine System Diseases

Parathyroid Diseases

Primary Hyperparathyroidism

All Drugs and Chemicals

Bone Density Conservation Agents

Hormones

Calcium

Calcium, Dietary

Parathyroid Hormone

One High Intensity focused ultrasound session before surgery. Use of appropriate energy for each patient

Ultrasonic ablation device

Philippe BONNICHON, MD

This study is a multicentre, open, uncontrolled trial for the observation of histological changes in parathyroid adenomas following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 10 patients with primary hyperparathyroidism scheduled for a parathyroidectomy. The patient will receive an HIFU treatment in the center of the adenoma before the surgery.

Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU) Treatment Procedure

Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU)Treatment Procedure: A Monocentre, Open, Uncontrolled Study

Theraclion

High Intensity Focused Ultrasound. This is not a comparative study

High Intensity Focused Ultrasound

Radu Mihai

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.

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.

High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

Calcium in the blood is measured from venepuncture

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'

Oxford University Hospitals NHS Trust

This is a single arm study, all subjects are planned to received HIFU treatment

HIFU Treatment

Age, Categorical

Age, Continuous

Sex: Female, Male

United Kingdom

Region of Enrollment

Mr Radu Mihai

This is a single arm study, all subjects are planned to receive HIFU treatment

The primary endpoint was not analysed because only one subject was entered and this subject was withdrawn from the study before 12 months after treatment.

Eucalcaemia

Ablation of the parathyroid gland by HIFU 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.

Allsubjects are planned to have HIFU Treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU) Treatment Procedure	NCT01060982	Primary Parathy...	Ultrasonic abla...	18 Years -	Theraclion
High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma	NCT01291498	Parathyroid Ade...	High Intensity ...	18 Years -	Oxford University Hospitals NHS Trust
High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma	NCT01291498	Parathyroid Ade...	High Intensity ...	18 Years -	Oxford University Hospitals NHS Trust

Spots Global Cancer Trial Database for primary parathyroid adenomas