Patients Over 75 Years Old With a Cancer DiscoveryFOGTEPNCT03370809
Assessment of Positron Emission Tomography to Early Detect Frailty in Onco-geriatry
A study testing Brain PET/CT step in people with Patients Over 75 Years Old With a Cancer Discovery, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Patients Over 75 Years Old With a Cancer Discovery
- What is being tested?
- Brain PET/CT step
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2018to 10 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU NANCY Brabois, nuclear medicine department
Vandœuvre-lès-Nancy, 54511
About this study
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).
Read more
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
- Being tested
- Brain PET/CT step
- Keywords
- Frailty, Oncogeriatric, PET 18F-FDG, SPM (Statistical Parametric Mapping), Neurology
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain PET/CT stepRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| patients over 75 years old with cancer discovery | Experimental | 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 Receives: Radiation: Brain PET/CT step |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through the completion of the study on average 24 months
Secondary outcomes (5)
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
Measured: 20 months, according to the results of neurology tests at the initial visit and at the 6 month
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
Measured: 20 months, according to the results of neurology tests at the initial visit and at the 6 month
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
Measured: 20 months, according to the results of neurology tests at the initial visit and at the 6 month
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
Measured: 20 months,according to the results of neurology tests at the initial visit and at the 6 month
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
Measured: 24 months,according to the death or not of the patients asked 12 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Oct 2018
- Primary completion24 May 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Over 75 Years Old With a Cancer DiscoveryStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine VERGER, Central Hospital, Nancy, France
- Investigators
- Antoine VERGER, MD, PhD, Principal investigator, CHRU NANCY, IADI INSERM U1254
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370809
- Sponsor's protocol ID
- PSS2017/FOGTEP-VERGER/VS
- Acronym
- FOGTEP
- Status last verified
- Aug 2022
- First submitted
- 7 Dec 2017
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Positron Emission Tomography to Early Detect Frailty in Onco-geriatry
- ClinicalTrials.gov ID
- NCT03370809
- Acronym / sponsor ID
- FOGTEP / PSS2017/FOGTEP-VERGER/VS
- Keywords
- Frailty, Oncogeriatric, PET 18F-FDG, SPM (Statistical Parametric Mapping), Neurology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients over 75 years old with cancer discovery | Experimental | Radiation: Brain PET/CT stepElderly 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 |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain PET/CT stepa 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 | Radiation | patients over 75 years old with cancer discovery |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine VERGER, MD, PhD principal investigator
CHRU NANCY, IADI INSERM U1254
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain PET/CT step in people with Patients Over 75 Years Old With a Cancer Discovery, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.