NCT06164938

Brief Summary

The aim of the study is to obtain information on cerebral glucose metabolism measured with the 18F-FDG PET technique in normal subjects without current or previous neurological or psychiatric pathologies in order to use the data obtained for voxel-based statistical analyzes for comparison with individual subjects ( patients with disease neurological or psychiatric) which will be evaluated with the same method to improve the specificity and diagnostic sensitivity of the FDG PET exam. The objective is to obtain a functional measure of brain glucose metabolism in every normal subject because this is a functional measure of brain activity. The subjects will represent different decades of age to have a wider range of comparison with patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2011

Completed
12.9 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

December 1, 2023

Last Update Submit

December 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Study of glucose metabolism with 18 F FDG PET

    Study of glucose metabolism with 18 F FDG PET in normal subjects without current or previous neurological or psychiatric pathologies in order to use the data obtained for statistical analyzes for comparison with individual subjects (patients with neurological or psychiatric) which will be evaluated with the same method to improve the diagnostic sensitivity of the FDG PET exam.

    1 year

Interventions

Diagnostic accuracyDIAGNOSTIC_TEST

The aim is to obtain a regional measure of brain glucose metabolism in each normal subject because this is a functional measure of brain activity.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

40 healthy volunteers, over 40 years of age, capable of understanding and wanting, who have not had a previous clinical history of neurological or psychiatric diseases, will be enrolled. Subjects with cognitive impairment and who at the time of recruitment are taking drugs active on the central nervous system will be excluded.

You may qualify if:

  • absence of neurological and psychiatric pathologies, negative pregnancy test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 11, 2023

Study Start

April 14, 2010

Primary Completion

January 12, 2011

Study Completion

January 12, 2011

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share