Study Stopped
The manufacturer is not currently supporting research in this indication.
High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2011
CompletedFirst Posted
Study publicly available on registry
February 8, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
June 25, 2014
CompletedDecember 18, 2017
July 1, 2014
2.2 years
February 7, 2011
June 27, 2013
November 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Eucalcaemia
Calcium in the blood is measured from venepuncture
12 months post-treatment
Secondary Outcomes (2)
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to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment.
Voice Morbidity
Up to one year post-treatment
Study Arms (1)
HIFU Treatment
OTHERHigh Intensity Focused Ultrasound. This is not a comparative study
Interventions
One or two HIFU sessions
Eligibility Criteria
You may qualify if:
- Primary Hyperparathyroidism (PHPT)
- Moderate/severe hypercalcaemia (Ca\>2.8mmol/L)
- Positive sestamibi scan demonstrating a cervical parathyroid adenoma
- Adenoma visible on ultrasound scan
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oxford University Hospitals NHS Trustlead
- Theraclioncollaborator
Study Sites (1)
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mr Radu Mihai
- Organization
- Oxford University Hospitals NHS Trust
Study Officials
- PRINCIPAL INVESTIGATOR
Radu Mihai
Oxford University Hospitals NHS Trust
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2011
First Posted
February 8, 2011
Study Start
April 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
December 18, 2017
Results First Posted
June 25, 2014
Record last verified: 2014-07