TriangleNCT01291498 · REGISTRY CONDITION SEARCH
High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- NA
- Status at capture
- TERMINATED
- Registry last update
- 2017-12-18
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- High Intensity Focused Ultrasound. This is not a comparative study
- intervention Names
- Device: High Intensity Focused Ultrasound
- label
- HIFU Treatment
- type
- OTHER
- interventions
- arm Group Labels
- HIFU Treatment
- description
- One or two HIFU sessions
- name
- High Intensity Focused Ultrasound
- other Names
- TH-One HIFU device
- type
- DEVICE
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Calcium in the blood is measured from venepuncture
- measure
- Eucalcaemia
- time Frame
- 12 months post-treatment
- secondary Outcomes
- description
- Ca in plasma
- measure
- 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.
- description
- 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'
- measure
- Voice Morbidity
- time Frame
- Up to one year post-treatment
Full study description
- 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.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-a30b1dbb04ec1c4ca1d6
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- primary nct id
- NCT01291498
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- payload
- clinical indication matching status
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- end exclusive
- true
- id
- nct-edge-a30b1dbb04ec1c4ca1d6
- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
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- occurrences
- context exact
- NCT01291498
- end
- 11
- exact text
- NCT01291498
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Parathyroid Cancer
- query disease state id
- ds-parathyroid-cancer
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-parathyroid-cancer-000.json
- source file sha256
- 2b4988b513f0b70e7c49c0c10cabf5241c1231b8e29e89b78dc9406bd8749c8a
- source json pointer
- /studies/15/protocolSection/identificationModule/nctId
- source kind
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- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 55aea330308c66630fb112323c261a643e1fcbe979a768742b30d07804f5aa9c
Preserved source evidence · Not medical advice