Preliminary Study Concerning the Validity of Parathyroid... | NCT02854345

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

NCT02854345

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Primary Hyperparathyroidism

Interventions

Tomoscintigraphic parathyroid imaging on a CZT camera

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2014Actual

Primary Completion Date

Sep 9, 2021Actual

Completion Date

Sep 9, 2021Actual

First Submitted Date

Jul 29, 2016

First Submission Date that Met QC Criteria

Jul 29, 2016

First Posted Date

Aug 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tomoscintigraphic parathyroid imaging on a CZT camera	Experimental	Tomoscintigraphic parathyroid imaging on a CZT camera	Device: Tomoscintigraphic parathyroid imaging on a CZT camera

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tomoscintigraphic parathyroid imaging on a CZT camera	Device		Tomoscintigraphic parathyroid imaging on a CZT camera

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Constantin Ungureanu, MD	Centre Hospitalier Universitaire de Besancon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Besancon		Besançon		25000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D049950	Hyperparathyroidism, Primary

Ancestor Terms

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided