InflammationNCT04001491
Interest of 18F-FDG Positron Emission Tomography in the Management of Fevers and Inflammatory Syndromes
An observational study of Inflammation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Patients aged 75 and over represent a heterogeneous population with fragile subjects who have a higher risk of poor tolerance to many tests and especially who have a risk of major functional loss in the event of hospitalization. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Inflammation
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to Aug 2020
- Phase
- Observational
- 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
Study population: Patient treated at the University Hospitals of Strasbourg for a check-up of fever or inflammatory syndrome, regardless of the duration of the evolution and the examinations already carried out
Who may be able to join
- Patient aged 75 years and over,
- Patients cared for at the HUS, in hospital or in consultation, during the defined period (from 01/05/2013 to 31/12/2018)
- Having had an 18FDG-PET/TDM
- For fever or inflammatory syndrome check-ups, regardless of the duration of the evolution and the examinations already carried out
- Patient who has not expressed opposition to the reuse of their data for the purposes of this research.
Who cannot join
- Patient who has expressed opposition to participating in the study
- Known explanation for fever or inflammatory syndrome
- Subjects under legal protection
- Subject under the protection of justice
- Subject under guardianship or curatorship
- Translated with www.DeepL.com/Translator
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Interne, diabète et maladies métaboliques - Médicale B
Strasbourg, 67091
Emmanuel ANDRES, MD, PhD, 33 3 88 11 50 66, emmanuel.andres@chru-strasbourg.fr
Carole GREUEZ, MD, 33 3 88 11 50 66, carole.greuez@chru-strasbourg.fr
About this study
Official title: Evaluation of the Interest of 18F-FDG Positron Emission Tomography in the Management of Unexplained Fevers and Inflammatory Syndromes in Elderly Subjects
Patients aged 75 and over represent a heterogeneous population with fragile subjects who have a higher risk of poor tolerance to many tests and especially who have a risk of major functional loss in the event of hospitalization. It is therefore necessary to adapt our prescriptions and not to impose on these patients an examination that is unnecessary. Or on the contrary, not to do without, out of ignorance, a minimally invasive examination that could be useful to these patients.
In this study, the investigators wish to evaluate the interest of the Pet-Scan in the therapeutic management of these elderly patients
- Conditions
- Inflammation
- Keywords
- Inflammation, Inflammatory syndromes, fever, Tomography, Positron emission at 18F-FDG, Elderly patients, Internal medicine, Pet-Scan
- Medical subject headings
- Inflammation, Fever
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the interest of the Pet-Scan in the therapeutic management of subjects aged 75 years and over with unexplained fever or inflammatory syndrome.
That is, to assess whether or not the therapeutic course of action has been modified by this examination, resulting in either the discontinuation or initiation of medical, surgical or radiotherapy treatment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel ANDRES, MD, PhD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001491
- Sponsor's protocol ID
- 7473
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest of 18F-FDG Positron Emission Tomography in the Management of Unexplained Fevers and Inflammatory Syndromes in Elderly Subjects
- ClinicalTrials.gov ID
- NCT04001491
- Acronym / sponsor ID
- 7473
- Conditions
- Inflammation
- Keywords
- Inflammation, Inflammatory syndromes, fever, Tomography, Positron emission at 18F-FDG, Elderly patients, Internal medicine, Pet-Scan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 28 Jun 2019 (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.
Patients aged 75 and over represent a heterogeneous population with fragile subjects who have a higher risk of poor tolerance to many tests and especially who have a risk of major functional loss in the event of hospitalization. It is therefore necessary to adapt our prescriptions and not to impose on these patients an examination that is unnecessary. Or on the contrary, not to do without, out of ignorance, a minimally invasive examination that could be useful to these patients.
In this study, the investigators wish to evaluate the interest of the Pet-Scan in the therapeutic management of these elderly patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patient treated at the University Hospitals of Strasbourg for a check-up of fever or inflammatory syndrome, regardless of the duration of the evolution and the examinations already carried out
Key inclusion criteria (5 listed)
- Patient aged 75 years and over,
- Patients cared for at the HUS, in hospital or in consultation, during the defined period (from 01/05/2013 to 31/12/2018)
- Having had an 18FDG-PET/TDM
- For fever or inflammatory syndrome check-ups, regardless of the duration of the evolution and the examinations already carried out
- Patient who has not expressed opposition to the reuse of their data for the purposes of this research.
Key exclusion criteria (6 listed)
- Patient who has expressed opposition to participating in the study
- Known explanation for fever or inflammatory syndrome
- Subjects under legal protection
- Subject under the protection of justice
- Subject under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the interest of the Pet-Scan in the therapeutic management of subjects aged 75 years and over with unexplained fever or inflammatory syndrome.
Time frame: 1 month
That is, to assess whether or not the therapeutic course of action has been modified by this examination, resulting in either the discontinuation or initiation of medical, surgical or radiotherapy treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
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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.
Emmanuel ANDRES, MD, PhD study director
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation, run by University Hospital, Strasbourg, 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Jun 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel ANDRES, MD, PhD (33 3 88 11 50 66, emmanuel.andres@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the interest of the Pet-Scan in the therapeutic management of subjects aged 75 years and over with unexplained fever or inflammatory syndrome. (time frame: 1 month). 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 28 Jun 2019.