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Preliminary Study Concerning the Validity of Parathyroid Exploration on a CZT Camera (PARAT-CZT)

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ClinicalTrials.gov Identifier: NCT02854345
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
The goal of this study is to assess the performance of parathyroid imaging on a cardiac-dedicated CZT camera, compared to planar pinhole imaging, in patients referred for primary hyperparathyroidism.

Condition or disease Intervention/treatment Phase
Primary Hyperparathyroidism Device: Tomoscintigraphic parathyroid imaging on a CZT camera Not Applicable

Detailed Description:
The goal is to determine if parathyroid tomoscintigraphy on a CZT camera can provide at least equivalent diagnostic performance, compared with planar pinhole imaging.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Preliminary Study Concerning the Validity of Parathyroid Exploration on a Discovery NM 530c CZT Camera
Study Start Date : September 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Experimental: Tomoscintigraphic parathyroid imaging on a CZT camera
Tomoscintigraphic parathyroid imaging on a CZT camera
Device: Tomoscintigraphic parathyroid imaging on a CZT camera



Primary Outcome Measures :
  1. Comparison of pathologic parathyroid detection performances between planar pinhole on Anger camera and tomoscintigraphy on CZT camera, gold standard being the pathological results after surgery [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • suffering from sporadic primary hyperparathyroidism
  • referred to the Nuclear Medicine Dept for a pre-operative scintigraphy of the parathyroid glands
  • who have given their written consent
  • who benefit from the French Government Medical Insurance

Exclusion Criteria:

  • pregnant women
  • ages < 18 or > 80 years
  • hyperparathyroidism recidive after a first surgery
  • secondary or tertiary hyperparathyroidism
  • Multiple endocrine Neoplasia (MEN) type I context or familial history of hyperparathyroidism
  • absence of written consent
  • non-beneficiary of the French Government Medical Insurance

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 ClinicalTrials.gov identifier (NCT number): NCT02854345


Contacts
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Contact: Constantin Ungureanu, MD cungureanu@chu-besancon.fr

Locations
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France
CHU Besancon Recruiting
Besancon, France, 25000
Contact: Constantin Ungureanu, MD       cungureanu@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Constantin Ungureanu, MD Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02854345     History of Changes
Other Study ID Numbers: P/2013/212
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
CZT camera
pinhole

Additional relevant MeSH terms:
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Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Parathyroid Hormone
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs