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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theraclion
ClinicalTrials.gov Identifier:
NCT01060982
First received: February 1, 2010
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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 Intervention
Primary Parathyroid Adenomas
Device: Ultrasonic ablation device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Theraclion:

Primary Outcome Measures:
  • Histology of excised gland. [ Time Frame: After surgery performed the same day as High intensity focused ultrasound treatment ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: February 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01060982

Locations
France
Cochin Hospital
Paris, France, 75014
Hôpital Privé des Peupliers
Paris, France, 75013
Sponsors and Collaborators
Theraclion
Investigators
Principal Investigator: Philippe BONNICHON, MD Cochin Hospital, Paris, Fance
  More Information

No publications provided

Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT01060982     History of Changes
Other Study ID Numbers: HIFU/F/12.02
Study First Received: February 1, 2010
Last Updated: May 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Theraclion:
Primary hyperparathyroidism
High Intensity Focused Ultrasound
Parathyroid tumor
Parathyroid hormone
Calcium

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 November 27, 2014