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

Not Applicable

• Conditions: Primary Hyperparathyroidism
• Interventions: Device: Tomoscintigraphic parathyroid imaging on a CZT camera

• Registration Number: NCT02854345
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18
• Primary Completion: 2019-03
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tomoscintigraphic parathyroid imaging on a CZT camera	Tomoscintigraphic parathyroid imaging on a CZT camera	Tomoscintigraphic parathyroid imaging on a CZT camera

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Besancon; 🇫🇷 Besancon, France