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Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI. (ATLATEP)

Primary Purpose

Brain Diseases

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
brain PET-MRI with 18F-FDG
Sponsored by
Institut de cancérologie Strasbourg Europe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Diseases focused on measuring FDG PET, PET-MRI, atlas, brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Subject in period of exclusion.

Sites / Locations

  • Institut de cancérologie Strasbourg Europe

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

18F-FDG injection

Arm Description

Health volunteers with 18-F-FDG injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 26, 2022
Last Updated
April 6, 2023
Sponsor
Institut de cancérologie Strasbourg Europe
Collaborators
ICube Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT05355857
Brief Title
Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.
Acronym
ATLATEP
Official Title
Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de cancérologie Strasbourg Europe
Collaborators
ICube Laboratory

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
Detailed Description
This is a prospective, monocentric, non-randomized study, with no direct individual benefit since it involved healthy volunteers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Diseases
Keywords
FDG PET, PET-MRI, atlas, brain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Healthy volunteers
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-FDG injection
Arm Type
Other
Arm Description
Health volunteers with 18-F-FDG injection
Intervention Type
Diagnostic Test
Intervention Name(s)
brain PET-MRI with 18F-FDG
Intervention Description
Realisation of a brain PET-MRI with 18F-FDG in 39 healthy volunteers
Primary Outcome Measure Information:
Title
Creation, from a representative set of brain PET-MRI images of healthy subjects, of a probabilistic atlas of normal FDG uptake in healthy volunteers
Description
Evaluation of tracer activity at the cerebral level on the acquisition images
Time Frame
30 minutes after 18F-FDG injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female aged 20 to 50 Absence of any history or cardiovascular, neurological or psychiatric deficit Signed the informed consent Exclusion Criteria: 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 Subject in period of exclusion.
Facility Information:
Facility Name
Institut de cancérologie Strasbourg Europe
City
Strasbourg
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.

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