Infections of the Implanted MaterialENDOTEPNCT02251262
Diagnostic Accuracy of 18FDG-PET-CT for Pacing or Defibrillation Lead Infection
A study testing Whole-body 18FDG-PET-CT scan in people with Infections of the Implanted Material and Endocarditis, run by University Hospital, Bordeaux at 6 sites in France.
Trial summary
With aging of the general population and broadening indications, the number of pacemaker recipients is steadily increasing. The incidence of infections of the implanted material, a dreaded major complication, is also rising. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections of the Implanted Material, Endocarditis
- What is being tested?
- Whole-body 18FDG-PET-CT scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 6 sitesFrance
- Study dates
- 22 Jun 2015to 19 Jun 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders
- Age > 18 years
- Patient referred for extraction of cardiac material (box and lead(s)) in the context of suspicion of material infection, including a patient with pocket infection.
- Possibility of carrying out PET-CT no more than 48 hours before extraction (or, exceptionally, no more than 7 days if the patient is not under antibiotic therapy).
- Informed written consent
- Affiliation to a social security system
Who cannot join
- Pregnant or breastfeeding women
- Patients with recent implantation (less than 2 months)
- Subjects placed under judicial protection
- Subjects participating in another study that includes an exclusion period on-going at the time of screening.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Grenoble - Hôpital A. Michallon
Grenoble, 38043
CHRU de Lille - Hôpital R. Salengro
Lille, 59037
AP-HM - Hôpital La Timone
Marseille, 13385
CHU de Bordeaux
Pessac, 33604
Clinique Pasteur
Toulouse, 31076
CHU de Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Assessment of Diagnostic Accuracy of 18FDG-PET-CT in Patients With Suspicion of Pacing or Defibrillation Lead Infection: a Prospective Multi-center Study
With aging of the general population and broadening indications, the number of pacemaker recipients is steadily increasing. The incidence of infections of the implanted material, a dreaded major complication, is also rising. The diagnosis is evident in presence of an abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to the lead. On the other hand, a proportion of patients present with less specific clinical manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious disorder of unknown origin despite detailed investigations. Without proof of lead infection, removal of the system without confirmation of its infection is usually proposed, despite the known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive culture of the leads implies that the leads were involved in the infectious process. In recent years, 18FDG-PET-CT scan has made promising contributions in different areas including imaging to detect infection at different organ sites. Absence of hyperfixation of the lead, identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing system infection.
The extraction of intracardiac implanted material, when it is indicated by the current standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients, even when they did not receive antibiotics before extraction.
Read more
The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current strategy may avoid or reduce these false-positives.
Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its sensitivity.
For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit; secondarily, an intervention for the extraction of the intra-cardiac material, under general anesthesia, will be practiced and then a bacteriological culture for extracted material will be required.
The end of study visit is complete the last day of material extraction. The follow up will last 2 to 7 days.
- Conditions
- Infections of the Implanted Material, Endocarditis
- Being tested
- Whole-body 18FDG-PET-CT scan
- Keywords
- Pacemaker, Endocarditis, 18FDG-PET-CT, Diagnostic accuracy, Pacing or defibrillation lead
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body 18FDG-PET-CT scanDevice
18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit.
| Study group | Role | What they receive |
|---|---|---|
| Whole-body 18FDG-PET-CT scan | Experimental | 18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit. Receives: Device: Whole-body 18FDG-PET-CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
A semi-quantitative visual interpretation of 18FDG-PET-CT in the diagnosis of infection of intracardiac device.
Index tests will be interpreted by nuclear medicine physician from the center where the patient was included with a semi-quantitative visual score.
Moreover, all 18FDG-PET-CT recordings will be sent to the coordinating center for centralized interpretation blind to the preceding one.
All 18FDG-PET-CT recordings will be stored until interpretation, and not used for the clinical management of the patient.
Index test interpretations will be carried out blind to any other information on the patient (clinical, biology,…).
Measured: up to 48 hours after inclusion (exceptionally, up to 7 days if the patient is not under antibiotic therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study start22 Jun 2015
- Primary completion19 Jun 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections of the Implanted MaterialStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre BORDACHAR, MD, Principal investigator, University Hospital, BordeauxPaul PEREZ, MD, PhD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251262
- Sponsor's protocol ID
- CHUBX 2013/31
- Acronym
- ENDOTEP
- Status last verified
- Feb 2022
- First submitted
- 24 Sep 2014
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Diagnostic Accuracy of 18FDG-PET-CT in Patients With Suspicion of Pacing or Defibrillation Lead Infection: a Prospective Multi-center Study
- ClinicalTrials.gov ID
- NCT02251262
- Acronym / sponsor ID
- ENDOTEP / CHUBX 2013/31
- Conditions
- Infections of the Implanted Material, Endocarditis
- Keywords
- Pacemaker, Endocarditis, 18FDG-PET-CT, Diagnostic accuracy, Pacing or defibrillation lead
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 22 Jun 2015 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 29 Sep 2014 (estimated)
- 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.
With aging of the general population and broadening indications, the number of pacemaker recipients is steadily increasing. The incidence of infections of the implanted material, a dreaded major complication, is also rising. The diagnosis is evident in presence of an abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to the lead. On the other hand, a proportion of patients present with less specific clinical manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious disorder of unknown origin despite detailed investigations. Without proof of lead infection, removal of the system without confirmation of its infection is usually proposed, despite the known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive culture of the leads implies that the leads were involved in the infectious process. In recent years, 18FDG-PET-CT scan has made promising contributions in different areas including imaging to detect infection at different organ sites. Absence of hyperfixation of the lead, identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing system infection.
The extraction of intracardiac implanted material, when it is indicated by the current standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients, even when they did not receive antibiotics before extraction.
The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current strategy may avoid or reduce these false-positives.
Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its sensitivity.
For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit; secondarily, an intervention for the extraction of the intra-cardiac material, under general anesthesia, will be practiced and then a bacteriological culture for extracted material will be required.
The end of study visit is complete the last day of material extraction. The follow up will last 2 to 7 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole-body 18FDG-PET-CT scan | Experimental | Device: Whole-body 18FDG-PET-CT scan18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both genders
- Age > 18 years
- Patient referred for extraction of cardiac material (box and lead(s)) in the context of suspicion of material infection, including a patient with pocket infection.
- Possibility of carrying out PET-CT no more than 48 hours before extraction (or, exceptionally, no more than 7 days if the patient is not under antibiotic therapy).
- Informed written consent
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women
- Patients with recent implantation (less than 2 months)
- Subjects placed under judicial protection
- Subjects participating in another study that includes an exclusion period on-going at the time of screening.
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 |
|---|---|---|
| Whole-body 18FDG-PET-CT scan18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit. | Device | Whole-body 18FDG-PET-CT scan |
Primary outcome
A semi-quantitative visual interpretation of 18FDG-PET-CT in the diagnosis of infection of intracardiac device.
Time frame: up to 48 hours after inclusion (exceptionally, up to 7 days if the patient is not under antibiotic therapy)
Index tests will be interpreted by nuclear medicine physician from the center where the patient was included with a semi-quantitative visual score. Moreover, all 18FDG-PET-CT recordings will be sent to the coordinating center for centralized interpretation blind to the preceding one. All 18FDG-PET-CT recordings will be stored until interpretation, and not used for the clinical management of the patient. Index test interpretations will be carried out blind to any other information on the patient (clinical, biology,…).
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 9 Feb 2022.
Related trials for Infections of the Implanted Material
RecruitingObservational study
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
Degenerative Disc Disease (DDD), Spinal Stenosis
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.
Pierre BORDACHAR, MD principal investigator
University Hospital, Bordeaux
Paul PEREZ, MD, PhD study chair
University Hospital, Bordeaux
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body 18FDG-PET-CT scan in people with Infections of the Implanted Material and Endocarditis, run by University Hospital, Bordeaux at 6 sites 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 6 inclusion and 4 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
A semi-quantitative visual interpretation of 18FDG-PET-CT in the diagnosis of infection of intracardiac device. (time frame: up to 48 hours after inclusion (exceptionally, up to 7 days if the patient is not under antibiotic therapy)). 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 9 Feb 2022.