High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Oxford University Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Theraclion
Information provided by:
Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01291498
First received: February 7, 2011
Last updated: June 16, 2011
Last verified: June 2011
  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 ]

Secondary Outcome Measures:
  • Eucalcaemia [ Time Frame: 6 weeks and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Voice Morbidity [ Time Frame: Up to one year post-treatment ] [ Designated as safety issue: Yes ]
  • Swallowing Morbidity [ Time Frame: Up to one year post-treatment ] [ Designated as safety issue: Yes ]
  • Parathyroid symptom score [ Time Frame: Up to one year post-treatment ] [ Designated as safety issue: No ]
    Pasieka's parathyroid sympton score


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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:

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

Locations
United Kingdom
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Jennifer Lee       jenni.lee@orh.nhs.uk   
Principal Investigator: Radu Mihai         
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 Radcliffe Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01291498     History of Changes
Other Study ID Numbers: HIFU-PT-2010-01
Study First Received: February 7, 2011
Last Updated: June 16, 2011
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Parathyroid Diseases

ClinicalTrials.gov processed this record on April 17, 2014