Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations (BDD TEP FDG)

September 13, 2016 updated by: Central Hospital, Nancy, France

Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations: Study of Principal Inter-individual Variation Factors

The purpose of this study is to define a reference population for FDG-PET neurological examinations starting from patients having FDG-PET to supervise a non-complicated lymphoma (tumor in remission, low disabling chronic tumor).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will also check normality of cerebral functions in this population and analyse the influence of various variation factors, such as age, sex ratio, education level, professional activity and neuropsychological test results on normal data.

This database could be later used as comparison to patient images defining the gravity and localization of their cerebral functional disorders.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France
        • Service de Médecine Nucléaire, Hôpital Central

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with tumor in remission or low disabling chronic tumor
  • No parenteral chemotherapy for at least 1 month
  • No glucocorticoid treatment
  • No general health modification (asthenia, anorexia, weight reduction)

Exclusion Criteria:

  • Patient having a known neurodegenerative disorder, a general disease or physical problems that can interfere with cognitive function
  • Patient with cerebral pathology history (epilepsy, vascular event, cerebral vascular malformation, tumor, severe cranial trauma, meningitis or infectious or inflammatory encephalitis, hydrocephalus, mental retardation…)
  • Patient not having at least 4 years of education
  • Patient having an anxiolytic or anti-depressive treatment
  • Patient refusing to participate to the study
  • Patient incapable to give informed consent (guardianship)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FDG-PET
Device: FDG-PET
FDG injection followed by cerebral examination with X ray spiral CT after 40 minutes and FDG-PET after 60 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence of neurological impairment detected during standard neurological examination
Time Frame: Day 0
Day 0
Mini-mental state score
Time Frame: Day 0
Day 0
Frontal Assessment Battery score
Time Frame: Day 0
Day 0
Mini International Neuropsychiatric Interview (DSM-IV) score
Time Frame: Day 0
Day 0
Montgomery-Åsberg depression rating scale
Time Frame: Day 0
Day 0
Absence of cerebral abnormalities detected with PET
Time Frame: Day 0
Day 0
Absence of cerebral abnormalities detected with X ray spiral CT
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Instrumental Activities of Daily Living evaluation
Time Frame: Day 0
Evaluation of the normality of cerebral function in study population
Day 0
Cerebral FDG distribution
Time Frame: Day 0
Voxel-based analysis with SPM software of PET data
Day 0
FDG mean activity in cerebral sections
Time Frame: Day 0
Automatic measurement of FDG mean fixation in cerebral sections with NeurogamTM (Segami) software in PET data
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Marie-Hélène Laurens, Service de Médecine Nucléaire, Hôpital Central, Nancy, France
  • Principal Investigator: Pierre-Yves MARIE, Service de Médecine Nucléaire, Hôpital Central, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2008-A00763-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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