NCT02854345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2021

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 years

First QC Date

July 29, 2016

Last Update Submit

September 5, 2024

Conditions

Primary Hyperparathyroidism

Keywords

CZT camerapinhole

Outcome Measures

Primary Outcomes (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

    6 months

Study Arms (1)

Tomoscintigraphic parathyroid imaging on a CZT camera

EXPERIMENTAL

Tomoscintigraphic parathyroid imaging on a CZT camera

Device: Tomoscintigraphic parathyroid imaging on a CZT camera

Interventions

Tomoscintigraphic parathyroid imaging on a CZT cameraDEVICE
Tomoscintigraphic parathyroid imaging on a CZT camera

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besancon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Constantin Ungureanu, MD

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 3, 2016

Study Start

September 4, 2014

Primary Completion

September 9, 2021

Study Completion

September 9, 2021

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)