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Assessment of Positron Emission Tomography to Early Detect Frailty in Onco-geriatry (FOGTEP)

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ClinicalTrials.gov Identifier: NCT03370809
Recruitment Status : Unknown
Verified January 2018 by Central Hospital, Nancy, France.
Recruitment status was:  Not yet recruiting
First Posted : December 12, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

Oncogeriatric frailty assessment is a multifactorial approach to determine the most appropriate treatment for the health status of elderly cancer patients and this assessment is recommended for patients over 75 years of age.

Oncogeriatric frailty is based on the SIOG-2 (International Society of Geriatric Oncology-2) clinical scale (assessing comorbidities, autonomy, nutrition, cognitive and thymic domains) defining 3 levels of frailty: (1) harmonious aging, (2) vulnerability (reversible stage), (3) fragility (irreversible stage).

So,the management of very old or very frailty patients with poor tolerance or compliance to treatment, often requires to defer standard treatment and monitoring procedures. That is detrimental to these patients prognosis. By contrast with elderly or very old patients without frailty criteria, could benefit from more efficient procedures.

More generally, frailty is associated directly with a cerebral impact on a cognitive or thymic status or indirectly with the cognitive or thymic impacts related with other components (nutritional or autonomy or walking poor status, comorbidities) 18F-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET), is routinely performed in follow-up cancer patients in most cases, including older patients, to detect neoplastic localizations on the whole body. It also accurately quantifies cerebral glycolytic metabolism when early brain recording is performed. Brain metabolism reflects the neuronal synaptic activity. It is generally decreased in particular brain areas due of neurodegenerative damage with a little or no symptom, of thymic involvement particular in depression or during accelerated cerebral aging of vascular origin. The impairment of the brain function of the elderly, as evidenced by 18F-FDG PET, is most often multifactorial, as frailty. Above all, brain changes are visualized with 18F-FDG PET much earlier than using neuropsychological tests, especially for cognitive impairment.

Our hypothesis is that with 18F-FDG PET, performed routinely in the initial assessment in elderly patients with cancer, it is also possible to obtain reliable and objective parameters of brain function and frailty. 18F-FDG PET is already used to identify cognitive and thymic impairment. This exam would help to assess the frailty and to adapt as best oncologic treatments some of which can also be neurotoxic. 18F-FDG PET is therefore related to brain function in frail patients


Condition or disease Intervention/treatment Phase
Patients Over 75 Years Old With a Cancer Discovery Radiation: Brain PET/CT step Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Positron Emission Tomography to Early Detect Frailty in Onco-geriatry
Estimated Study Start Date : July 18, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: patients over 75 years old with cancer discovery
Elderly patients with cancer have a 18F-FDG PET whole body performed routinely in the initial assessment . A cerebral recording is added 45 minutes after the 18F-FDG injection and just before the registered whole body
Radiation: Brain PET/CT step
a cerebral PET/CT will be registered on the 45th minute after 18F-FDG injection and just before the whole body recording. This recording does'nt need a new injection but needs a low dose scanner




Primary Outcome Measures :
  1. Volume of brain with damages detected by quantitative analysis SPM (Statistical Parametric Mapping) [ Time Frame: through the completion of the study on average 24 months ]
    Metabolism of PET cerebral images and correlation with different groups of frailty at the initial visit


Secondary Outcome Measures :
  1. Volume of brain with damages detected by quantitative analysis SPM between 2 patient's group with MMSE (MiniMental State Examination) results and threshold value as 24 [ Time Frame: 20 months, according to the results of neurology tests at the initial visit and at the 6 month ]
    Metabolism of PET cerebral images and correlation into 2 frailty groups defined by their results MMSE (MiniMental State Examination) test : group 1 with MMSE < or = 24 and group 2 with MMSE>24, at the initial visit and at the 6 month visit

  2. Volume of brain with damages detected by quantitative analysis SPM between 2 patient's groups with GDS (Geriatric Depression Scale) results and threshold value as 5 [ Time Frame: 20 months, according to the results of neurology tests at the initial visit and at the 6 month ]
    Metabolism of PET cerebral images and correlation into 2 frailty groups defined by their results GDS (Geriatric Depression Scale) test : group 1 with GDS < or = 5 and group 2 with GDS>5 at the initial visit and at the 6 month visit

  3. Volume of brain with damages detected by quantitative analysis SPM between different groups according to the SIOG-2 scale [ Time Frame: 20 months, according to the results of neurology tests at the initial visit and at the 6 month ]
    Metabolism of PET cerebral images and correlation into different patients groups according to the SIOG-2 scale during the geriatric visit over 6 months

  4. Volume of brain with damages detected by quantitative analysis SPM between 2 patient's groups according to an unscheduled hospitalisation over 6 months or no [ Time Frame: 20 months,according to the results of neurology tests at the initial visit and at the 6 month ]
    Metabolism of PET cerebral images and correlation into 2 patients groups with known frailty or no defined by an unscheduled hospitalisations at 6 months

  5. Volume of brain with damages detected by quantitative analysis SPM between 2 patient's groups according to non cancer related death at 12 months or no [ Time Frame: 24 months,according to the death or not of the patients asked 12 months after the inclusion ]
    Metabolism of PET cerebral images and correlation with known excess frailty or no defined by a death non cancer related at 12 months



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who are more than 75 years old with written informed consent
  • patients referred for 18F-FDG PET in an oncological disease newly diagnosed
  • patients insured under social security

Exclusion Criteria:

  • patients with disease in final stage and life expectancy less than 6 months
  • patients under guardianship or curators
  • patients with abnormal neurological tests: MMS< 27, with neoplastic or other brain lesions or showing ischemic or cerebral stroke damage
  • confused or agitated patient unable to realize a PET
  • radiotherapy ou chemiotherapy one year at least of the patient enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370809


Contacts
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Contact: Antoine VERGER, MD 03 83 15 55 67 ext +33 a.verger@chru-nancy.fr
Contact: Véronique ROCH, MSc 03 83 15 42 76 ext +33 v.roch@chru-nancy.fr

Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Antoine VERGER, MD, PhD CHRU NANCY, IADI INSERM U1254
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03370809    
Other Study ID Numbers: PSS2017/FOGTEP-VERGER/VS
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
Frailty
Oncogeriatric
PET 18F-FDG
SPM (Statistical Parametric Mapping)
Neurology
Additional relevant MeSH terms:
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Frailty
Pathologic Processes