Parathyroid AdenomasNCT01291498
High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma
A study testing High Intensity Focused Ultrasound in people with Parathyroid Adenomas, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parathyroid Adenomas
- What is being tested?
- High Intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Hyperparathyroidism (PHPT)
- Moderate/severe hypercalcaemia (Ca>2.8mmol/L)
- Positive sestamibi scan demonstrating a cervical parathyroid adenoma
- Adenoma visible on ultrasound scan
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parathyroid Adenomas
- Being tested
- High Intensity Focused Ultrasound
- Keywords
- Primary Parathyroid Adenomas
- Medical subject headings
- Parathyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Focused UltrasoundDevice
Also called TH-One HIFU device
One or two HIFU sessions
| Study group | Role | What they receive |
|---|---|---|
| HIFU Treatment | Other | High Intensity Focused Ultrasound. This is not a comparative study Receives: Device: High Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eucalcaemia
Calcium in the blood is measured from venepuncture
Measured: 12 months post-treatment
Secondary outcomes (2)
Eucalcaemia
Ca in plasma
Measured: 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
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'
Measured: Up to one year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: The manufacturer is not currently supporting research in this indication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parathyroid AdenomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Theraclion
- Responsible party
- Sponsor
- Investigators
- Radu Mihai, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291498
- Sponsor's protocol ID
- HIFU-PT-2010-01
- Status last verified
- Jul 2014
- First submitted
- 7 Feb 2011
- Last updated
- 18 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma
- ClinicalTrials.gov ID
- NCT01291498
- Acronym / sponsor ID
- HIFU-PT-2010-01
- Conditions
- Parathyroid Adenomas
- Keywords
- Primary Parathyroid Adenomas
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The manufacturer is not currently supporting research in this indication.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Theraclion
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Posted 25 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU Treatment | Other | Device: High Intensity Focused UltrasoundHigh Intensity Focused Ultrasound. This is not a comparative study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary Hyperparathyroidism (PHPT)
- Moderate/severe hypercalcaemia (Ca>2.8mmol/L)
- Positive sestamibi scan demonstrating a cervical parathyroid adenoma
- Adenoma visible on ultrasound scan
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Focused UltrasoundAlso: TH-One HIFU deviceOne or two HIFU sessions | Device | HIFU Treatment |
Primary outcome
Eucalcaemia
Time frame: 12 months post-treatment
Calcium in the blood is measured from venepuncture
2 secondary outcomes
Eucalcaemia
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.
Voice Morbidity
Time frame: Up to one year post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Parathyroid Adenomas
RecruitingEarly Phase 1
Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas
Hyperparathyroidism
RecruitingPhase 2/3
Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Primary Hyperparathyroidism, Parathyroid Cancer
Enrolling by invitationObservational study
Parathyroid Adenoma Detection With Rubidium-82 Imaging
Parathyroid Adenomas, Hyperparathyroidism, Primary
Active, not recruitingPhase 2
Agnostic Therapy in Rare Solid Tumors
Urachal Cancer, Parathyroid Carcinoma
RecruitingPhase 2/3
99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
Parathyroid Adenoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radu Mihai principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Focused Ultrasound in people with Parathyroid Adenomas, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eucalcaemia (time frame: 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.