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

Primary Hyperparathyroidism Clinical Trial

— PARAT-CZT  

Official title:

Preliminary Study Concerning the Validity of Parathyroid Exploration on a Discovery NM 530c CZT Camera

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02854345
• Other study ID #: P/2013/212
• Status: Recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2019

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Constantin Ungureanu, MD
• Email: cungureanu[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Intervention

Device:
• Tomoscintigraphic parathyroid imaging on a CZT camera

Locations

Country	Name	City	State
France	CHU Besancon	Besancon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months