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

Primary Purpose

Primary Hyperparathyroidism

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tomoscintigraphic parathyroid imaging on a CZT camera
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Hyperparathyroidism focused on measuring CZT camera, pinhole

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU BesanconRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tomoscintigraphic parathyroid imaging on a CZT camera

Arm Description

Tomoscintigraphic parathyroid imaging on a CZT camera

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 29, 2016
Last Updated
July 17, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02854345
Brief Title
Preliminary Study Concerning the Validity of Parathyroid Exploration on a CZT Camera
Acronym
PARAT-CZT
Official Title
Preliminary Study Concerning the Validity of Parathyroid Exploration on a Discovery NM 530c CZT Camera
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperparathyroidism
Keywords
CZT camera, pinhole

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tomoscintigraphic parathyroid imaging on a CZT camera
Arm Type
Experimental
Arm Description
Tomoscintigraphic parathyroid imaging on a CZT camera
Intervention Type
Device
Intervention Name(s)
Tomoscintigraphic parathyroid imaging on a CZT camera
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Constantin Ungureanu, MD
Email
cungureanu@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantin Ungureanu, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besancon
City
Besancon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constantin Ungureanu, MD
Email
cungureanu@chu-besancon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preliminary Study Concerning the Validity of Parathyroid Exploration on a CZT Camera

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