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Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU)Treatment Procedure: A Monocentre, Open, Uncontrolled Study


N/A
18 Years
N/A
Open (Enrolling)
Both
Primary Parathyroid Adenomas

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Trial Information

Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU)Treatment Procedure: A Monocentre, Open, Uncontrolled Study


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Histology of excised gland.

Outcome Time Frame:

After surgery performed the same day as High intensity focused ultrasound treatment

Safety Issue:

No

Principal Investigator

Philippe BONNICHON, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cochin Hospital, Paris, Fance

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

HIFU/F/12.02

NCT ID:

NCT01060982

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Primary Parathyroid Adenomas
  • Primary hyperparathyroidism
  • High Intensity Focused Ultrasound
  • Parathyroid tumor
  • Parathyroid hormone
  • Calcium
  • Adenoma
  • Parathyroid Neoplasms

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