Assessment of Positron Emission Tomography to Early Detect Frailty in Onco-geriatry (FOGTEP)
Primary Purpose
Patients Over 75 Years Old With a Cancer Discovery
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brain PET/CT step
Sponsored by
About this trial
This is an interventional diagnostic trial for Patients Over 75 Years Old With a Cancer Discovery focused on measuring Frailty, Oncogeriatric, PET 18F-FDG, SPM (Statistical Parametric Mapping), Neurology
Eligibility 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
Sites / Locations
- CHRU NANCY Brabois, nuclear medicine department
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients over 75 years old with cancer discovery
Arm Description
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
Outcomes
Primary Outcome Measures
Volume of brain with damages detected by quantitative analysis SPM (Statistical Parametric Mapping)
Metabolism of PET cerebral images and correlation with different groups of frailty at the initial visit
Secondary Outcome Measures
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
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
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
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
Volume of brain with damages detected by quantitative analysis SPM between different groups according to the SIOG-2 scale
Metabolism of PET cerebral images and correlation into different patients groups according to the SIOG-2 scale during the geriatric visit over 6 months
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
Metabolism of PET cerebral images and correlation into 2 patients groups with known frailty or no defined by an unscheduled hospitalisations at 6 months
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
Metabolism of PET cerebral images and correlation with known excess frailty or no defined by a death non cancer related at 12 months
Full Information
NCT ID
NCT03370809
First Posted
December 7, 2017
Last Updated
August 23, 2022
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT03370809
Brief Title
Assessment of Positron Emission Tomography to Early Detect Frailty in Onco-geriatry
Acronym
FOGTEP
Official Title
Assessment of Positron Emission Tomography to Early Detect Frailty in Onco-geriatry
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
May 24, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Over 75 Years Old With a Cancer Discovery
Keywords
Frailty, Oncogeriatric, PET 18F-FDG, SPM (Statistical Parametric Mapping), Neurology
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients over 75 years old with cancer discovery
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Brain PET/CT step
Intervention Description
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 Measure Information:
Title
Volume of brain with damages detected by quantitative analysis SPM (Statistical Parametric Mapping)
Description
Metabolism of PET cerebral images and correlation with different groups of frailty at the initial visit
Time Frame
through the completion of the study on average 24 months
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
20 months, according to the results of neurology tests at the initial visit and at the 6 month
Title
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
Description
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
Time Frame
20 months, according to the results of neurology tests at the initial visit and at the 6 month
Title
Volume of brain with damages detected by quantitative analysis SPM between different groups according to the SIOG-2 scale
Description
Metabolism of PET cerebral images and correlation into different patients groups according to the SIOG-2 scale during the geriatric visit over 6 months
Time Frame
20 months, according to the results of neurology tests at the initial visit and at the 6 month
Title
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
Description
Metabolism of PET cerebral images and correlation into 2 patients groups with known frailty or no defined by an unscheduled hospitalisations at 6 months
Time Frame
20 months,according to the results of neurology tests at the initial visit and at the 6 month
Title
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
Description
Metabolism of PET cerebral images and correlation with known excess frailty or no defined by a death non cancer related at 12 months
Time Frame
24 months,according to the death or not of the patients asked 12 months after the inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine VERGER, MD, PhD
Organizational Affiliation
CHRU NANCY, IADI INSERM U1254
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU NANCY Brabois, nuclear medicine department
City
Vandoeuvre les Nancy cedex
ZIP/Postal Code
54511
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Assessment of Positron Emission Tomography to Early Detect Frailty in Onco-geriatry
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