- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01060982
Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU) Treatment Procedure
Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU)Treatment Procedure: A Monocentre, Open, Uncontrolled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Paris, France, 75014
- Cochin Hospital
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Paris, France, 75013
- Hôpital Privé des Peupliers
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: HIFU treatment
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One High Intensity focused ultrasound session before surgery.
Use of appropriate energy for each patient
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Histology of excised gland.
Time Frame: After surgery performed the same day as High intensity focused ultrasound treatment
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After surgery performed the same day as High intensity focused ultrasound treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philippe BONNICHON, MD, Cochin Hospital, Paris, Fance
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIFU/F/12.02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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