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

NCT ID: NCT02858167

Last Updated: 2016-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-02-28

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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FDG-PET

Group Type EXPERIMENTAL

FDG-PET

Intervention Type DEVICE

FDG injection followed by cerebral examination with X ray spiral CT after 40 minutes and FDG-PET after 60 minutes

Interventions

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FDG-PET

FDG injection followed by cerebral examination with X ray spiral CT after 40 minutes and FDG-PET after 60 minutes

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Hélène Laurens

Role: PRINCIPAL_INVESTIGATOR

Service de Médecine Nucléaire, Hôpital Central, Nancy, France

Pierre-Yves MARIE

Role: PRINCIPAL_INVESTIGATOR

Service de Médecine Nucléaire, Hôpital Central, Nancy, France

Locations

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Service de Médecine Nucléaire, Hôpital Central

Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2008-A00763-52

Identifier Type: -

Identifier Source: org_study_id

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