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Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU) Treatment Procedure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01060982
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : May 6, 2014
Information provided by (Responsible Party):

Brief Summary:

This study is a multicentre, open, uncontrolled trial for the observation of histological changes in parathyroid adenomas following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 10 patients with primary hyperparathyroidism scheduled for a parathyroidectomy. The patient will receive an HIFU treatment in the center of the adenoma before the surgery.

Condition or disease Intervention/treatment Phase
Primary Parathyroid Adenomas Device: Ultrasonic ablation device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU)Treatment Procedure: A Monocentre, Open, Uncontrolled Study
Study Start Date : February 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: HIFU treatment Device: Ultrasonic ablation device
One High Intensity focused ultrasound session before surgery. Use of appropriate energy for each patient
Other Name: TH-One

Primary Outcome Measures :
  1. Histology of excised gland. [ Time Frame: After surgery performed the same day as High intensity focused ultrasound treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patient 18 years or older.
  • Patients with diagnosed primary hyperparathyroidism (clinical symptoms and/or biochemical disturbances) scheduled for parathyroidectomy.
  • One diseased parathyroid gland, visualized by ultrasonography.
  • The diseased targeted parathyroid gland accessible for HIFU treatment (anonymised ultrasonographic images to be sent to the sponsor's technical team for validation).
  • Normal pretreatment nasofibroscopy.
  • Voluntary signed informed consent.

Exclusion Criteria:

  • Inaccessibility or high risk of targeting neighbouring structures, as evidenced by:

    • Targeted area located less than 2 mm laterally from the oesophagus or the carotid artery
    • Targeted area located less than 3 mm laterally from the trachea,
    • Significant hyperechoic area with a posterior shadow located less than 10 mm behind the targeted area (behind to be understood as posterior to the targeted area in the direction of the HIFU beam)
  • Investigator appreciation of any abnormal blood test that could contraindicate treatment with HIFU (bleeding abnormalities)
  • Known spondylitis of the neck vertebrae
  • Head and/or neck disease that prevents hyperextension of neck.
  • Known history of parathyroid or other neoplasias in the neck region.
  • History of neck irradiation
  • Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit
  • Pregnant or lactating woman.
  • Female patient of childbearing age if not having a suitable contraception method.
  • Patients who have received any investigational drug or device within the last 15 days and/or patients who are currently participating in another clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01060982

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Hôpital Privé des Peupliers
Paris, France, 75013
Cochin Hospital
Paris, France, 75014
Sponsors and Collaborators
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Principal Investigator: Philippe BONNICHON, MD Cochin Hospital, Paris, Fance
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Responsible Party: Theraclion Identifier: NCT01060982    
Other Study ID Numbers: HIFU/F/12.02
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014
Keywords provided by Theraclion:
Primary hyperparathyroidism
High Intensity Focused Ultrasound
Parathyroid tumor
Parathyroid hormone
Additional relevant MeSH terms:
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Parathyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Parathyroid Diseases