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The manufacturer is not currently supporting research in this indication.
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| Name | Class |
|---|---|
| Theraclion | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIFU Treatment | Other | High Intensity Focused Ultrasound. This is not a comparative study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Focused Ultrasound | Device | One or two HIFU sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eucalcaemia | Calcium in the blood is measured from venepuncture | 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Eucalcaemia | Ca in plasma | 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. |
| Voice Morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Radu Mihai | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
The company manufacturing the device reviewed patient's images before confirming eligibility for treatment.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | HIFU Treatment | This is a single arm study, all subjects are planned to receive HIFU treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HIFU Treatment | This is a single arm study, all subjects are planned to received HIFU treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Eucalcaemia | Calcium in the blood is measured from venepuncture | 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. | Posted | 12 months post-treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIFU Treatment | This is a single arm study, all subjects are planned to received HIFU treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Radu Mihai | Oxford University Hospitals NHS Trust | radu.mihai@ouh.nhs.uk |
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| ID | Term |
|---|---|
| D010282 | Parathyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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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' |
| Up to one year post-treatment |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | Eucalcaemia | Ca in plasma | 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. | Posted | Number | mmol/L | 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. |
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|
|
| 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' | Posted | Number | units on a scale | Up to one year post-treatment |
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| 0 |
| 1 |
| 0 |
| 1 |
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| D004700 |
| Endocrine System Diseases |
| D010279 | Parathyroid Diseases |