Establish the First International Database on Semi-quanti... | NCT06828705

Status Module

Record Verification Date

Jun 2026

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

Jul 30, 2025Actual

Primary Completion Date

Aug 15, 2025Actual

Completion Date

Nov 30, 2025Actual

First Submitted Date

Jan 31, 2025

First Submission Date that Met QC Criteria

Feb 11, 2025

First Posted Date

Feb 14, 2025Actual

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

Jun 23, 2026

Last Update Posted Date

Jun 25, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Datscan scintigraphy is a nuclear medicine examination allowing the diagnosis of neurodegenerative pathologies linked to damage to dopaminergic pathways, such as Parkinson's disease (essential for the differential diagnosis of essential tremor).

Detailed Description

There are several types of cameras allowing its performance:

Conventional Anger cameras and,
CZT (Cadmium-Zinc-Telluride) semiconductor cameras. At the Nancy University Hospital, the nuclear medicine department has a wide-field Cadmium-Zinc-Telluride camera: VERITON-CT (Spectrum Dynamics). The interpretation of this examination is purely visual.

The objectives are therefore to:

Create the first international database of semi-quantitative values in 3D scintigraphy with Datscan performed with a VERITON-CT camera.
Compare this database with another database from a conventional Anger camera (Lyon Nuclear Medicine Department) to show its superiority.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Name	Type	Description	Arm Group Labels	Other Names
datscan scintigraphy	Other	Semi-quantitative analysis on Datscan imaging scintigraphy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To create the first international database of Datscan by camera VERITON-CT.	Fixation ratio of central gray nuclei of the brain namely, the global striatum, caudate nuclei, putamens	One day

Secondary Outcomes

Measure	Description	Time Frame
Compare this database with another database from another type of camera (Lyon nuclear medicine team) to show its superiority.	Identical to the primary evaluation criterion compared to those of the Lyon database.	One day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients who have undergone a Datscan scintigraphy on the VERITON camera in the nuclear medicine department of the Nancy University Hospital and who have an established clinical diagnosis, -Absence of neurodegenerative pathology or Parkinson's disease or Lewy body disease.
The clinical diagnosis can only be established after two years of clinical follow-up.

Exclusion Criteria:

Excluded from this research will be the patients opposed to the use of their data, minors, atypical Parkinsonian syndromes,
patients who died before two years of clinical follow-up,
patients who had their Datscan examination carried out on a camera other than the VERITON and - patients lost to follow-up.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients who have undergone a Datscan® scintigraphy on the VERITON-CT camera in the nuclear medicine department of the Nancy University Hospital and who have an established clinical diagnosis, in the absence of neurodegenerative pathology or Parkinson's disease or Lewy body disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU NANCY Brabois, nuclear medicine department		Vandœuvre-lès-Nancy		54511	France

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.