Clinical trial NCT01291498: High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma
Official title: High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parathyroid Adenomas
Keywords: Primary Parathyroid Adenomas
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Theraclion
First posted: 2011-02-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Eucalcaemia
timeFrame: 12 months post-treatment
Secondary outcomes:
measure: Eucalcaemia
timeFrame: 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.
measure: Voice Morbidity
timeFrame: Up to one year post-treatment
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Radu Mihai
role: PRINCIPAL_INVESTIGATOR
References: