High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

This study has been terminated.
(The manufacturer is not currently supporting research in this indication.)
Sponsor:
Collaborator:
Theraclion
Information provided by (Responsible Party):
Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01291498
First received: February 7, 2011
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Parathyroid Adenomas
Device: High Intensity Focused Ultrasound

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

Resource links provided by NLM:


Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • Eucalcaemia [ Time Frame: 12 months post-treatment ] [ Designated as safety issue: No ]
    Calcium in the blood is measured from venepuncture


Secondary Outcome Measures:
  • 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to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment. ] [ Designated as safety issue: No ]
    Ca in plasma

  • Voice Morbidity [ Time Frame: Up to one year post-treatment ] [ Designated as safety issue: Yes ]
    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'


Enrollment: 1
Study Start Date: April 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HIFU Treatment
High Intensity Focused Ultrasound. This is not a comparative study
Device: High Intensity Focused Ultrasound
One or two HIFU sessions
Other Name: TH-One HIFU device

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291498

Locations
United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Theraclion
Investigators
Principal Investigator: Radu Mihai Oxford University Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01291498     History of Changes
Other Study ID Numbers: HIFU-PT-2010-01
Study First Received: February 7, 2011
Results First Received: June 27, 2013
Last Updated: July 21, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Oxford University Hospitals NHS Trust:
Primary Parathyroid Adenomas

Additional relevant MeSH terms:
Adenoma
Parathyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Parathyroid Diseases

ClinicalTrials.gov processed this record on October 22, 2014