NCT05355857

Brief Summary

With 18F-FDG PET, we have few atlases of normality allowing the realization of objective quantitative analyses. An atlas of normality is a probabilistic atlas of normal FDG uptake from a representative set of brain PET images of healthy subjects. This type of atlas is essential for intra- and inter-individual comparisons. Accurate quantitative analysis of brain 18F-FDG PET images acquired on a hybrid PET system has been shown to require an institutional normal database for statistical analyzes (Akdemir et al., JNM 2017 and Della Rosa et al Neuroinformatics, 2014).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 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

First Submitted

Initial submission to the registry

April 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2023

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

April 26, 2022

Last Update Submit

April 6, 2023

Conditions

Brain Diseases

Keywords

FDG PETPET-MRIatlasbrain

Outcome Measures

Primary Outcomes (1)

  • Creation, from a representative set of brain PET-MRI images of healthy subjects, of a probabilistic atlas of normal FDG uptake in healthy volunteers

    Evaluation of tracer activity at the cerebral level on the acquisition images

    30 minutes after 18F-FDG injection

Study Arms (1)

18F-FDG injection

OTHER

Health volunteers with 18-F-FDG injection

Diagnostic Test: brain PET-MRI with 18F-FDG

Interventions

brain PET-MRI with 18F-FDGDIAGNOSTIC_TEST

Realisation of a brain PET-MRI with 18F-FDG in 39 healthy volunteers

18F-FDG injection

Eligibility Criteria

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

You may qualify if:

  • Male or female aged 20 to 50
  • Absence of any history or cardiovascular, neurological or psychiatric deficit
  • Signed the informed consent

You may not qualify if:

  • Contraindication to the realization of an MRI or PET and to the injection of 18F-FDG
  • People using a pacemaker or insulin pump
  • People wearing a metal prosthesis or an intracerebral clip
  • People with intraocular metal splinters
  • People with a pathology considered incompatible for the production of the atlas according to the investigator
  • Pregnant women and breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, France

Location

MeSH Terms

Conditions

Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Design

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

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 2, 2022

Study Start

August 10, 2022

Primary Completion

March 23, 2023

Study Completion

March 23, 2023

Last Updated

April 7, 2023

Record last verified: 2023-04

Locations

FR(1)