Parathyroid Adenomas
Conditions
Keywords
Primary Parathyroid Adenomas
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.
Interventions
One or two HIFU sessions
Sponsors
Theraclion
Oxford University Hospitals NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eucalcaemia | 12 months post-treatment | Calcium in the blood is measured from venepuncture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voice Morbidity | 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' |
| Eucalcaemia | 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 |
Countries
United Kingdom
Participant flow
Recruitment details
One patient entered the study. Screening and informed consent was conducted on 19 April 2011 and treatment was conducted at the Churchill Hospital on 31 May 2011
Pre-assignment details
The company manufacturing the device reviewed patient's images before confirming eligibility for treatment.
Participants by arm
| Arm | Count |
|---|---|
| HIFU Treatment This is a single arm study, all subjects are planned to received HIFU treatment | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | HIFU Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 61 years |
| Region of Enrollment United Kingdom | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Eucalcaemia
Calcium in the blood is measured from venepuncture
Time frame: 12 months post-treatment
Population: 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.
Secondary
Eucalcaemia
Ca in plasma
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.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIFU Treatment | Eucalcaemia | 1 mmol/L |
Secondary
Voice Morbidity
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'
Time frame: Up to one year post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIFU Treatment | Voice Morbidity | 1 units on a scale |