Vascular Prosthesis InfectionPhase 3LEUCOPRONCT02538133
Study Assessing Hybrid SPECT-CT With Labeled Leukocytes for Diagnosis of Vascular Prosthesis Infections
A Phase 3 study testing 99mTc-Exametazime (HMPAO)-labeled leukocytes in people with Vascular Prosthesis Infection, run by University Hospital, Angers at 3 sites in France.
Trial summary
Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis is often difficult (germs are found only in 50% of cases). Conventional imagery is often non-specific and difficult to interpret especially in early postoperative phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Prosthesis Infection
- What is being tested?
- 99mTc-Exametazime (HMPAO)-labeled leukocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2015to Jan 2020
- Phase
- Phase 3
- 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
- patient of more than 18 years old
- Patient with a subdiaphragmatic vascular prosthesis
- Vascular prosthesis infection suspected with clinical (flow from the scare and/or local pain and/or erythema and/or persistent fever and/or bacteraemia) and/or biological (inflammatory syndrome : elevated C-reactive protein and/or erythrocyte sedimentation rate (ESR) and/or white blood cells increased) infection signs
- Patient willing to participate with a signed informed consent
- Patient covered by a healthcare insurance
Who cannot join
- Pregnant women or of childbearing age without effective contraception
- Prosthesis limited to a bare stent.
- Patient who has been committed to an institution by legal or regulatory order
- Contraindications for labeled leukocytes scintigraphy realization :
- Restlessness, inability to keep still lie at least 1 hour
- Claustrophobia
- Poor compliance predictable or impaired general condition making it impossible to carry out the examination
- Refusal to participate in the study
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
CHU
Angers, 49933
Hervé Rakotonirina
Hervé Rakotonirina
- Recruiting
CH
Le Mans, 72037
Helene Loubiere
Hélène Loubière
- Recruiting
CHRU
Strasbourg, 67091
Nabil Chakfe
Nabil Chakfe
About this study
Official title: Tomoscintigraphie Hybride Aux Leucocytes Marqués Dans le Diagnostic Des Infections de Prothèses Vasculaires.
Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis is often difficult (germs are found only in 50% of cases). Conventional imagery is often non-specific and difficult to interpret especially in early postoperative phase. Leukocytes isolated from the patient's blood are labeled with a radiopharmaceutical technetium 99mTc-HMPAO.
The aim of this study is to assess the overall diagnostic performance of scintigraphy (hybrid SPEC-CT) with labeled leucocytes in diagnosis of subdiaphragmatic vascular prothesis infection.
- Conditions
- Vascular Prosthesis Infection
- Being tested
- 99mTc-Exametazime (HMPAO)-labeled leukocytes
- Keywords
- 99mTc-Exametazime (HMPAO)-Labeled Leukocytes, suspected subdiaphragmatic vascular prosthesis infection, diagnosis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-Exametazime (HMPAO)-labeled leukocytesBiological
Hybrid tomoscintigraphy with labeled leucocytes for patients with suspected vascular prosthesis infection
| Study group | Role | What they receive |
|---|---|---|
| 99mTc-Exametazime (HMPAO)-labeled leucocytes | Experimental | Not described Receives: Biological: 99mTc-Exametazime (HMPAO)-labeled leukocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients correctly classified by interpreting scintigraphy for the diagnosis of vascular prosthesis infection. The percentage of patients correctly classified is assessed comparing with the diagnostic established by the expert committee.
A visual analysis of scintigraphy for diagnosing vascular prosthesis infection. Scintigraphy is considered positive if at least one abnormal localization is seen at vascular prosthesis and if intensity is increasing over time on 20-24h delayed images.
Measured: One year after inclusion when vascular prosthesis infection is suspected and hybrid SPEC-CT with labeled leukocytes has been performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Prosthesis InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- HERVE RAKOTONIRINA, Dr, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538133
- Sponsor's protocol ID
- 49RC14_0072
- Other IDs
- 2015-001342-28, 2015
- Acronym
- LEUCOPRO
- Status last verified
- Aug 2015
- First submitted
- 30 Jul 2015
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomoscintigraphie Hybride Aux Leucocytes Marqués Dans le Diagnostic Des Infections de Prothèses Vasculaires.
- ClinicalTrials.gov ID
- NCT02538133
- Acronym / sponsor ID
- LEUCOPRO / 49RC14_0072
- Conditions
- Vascular Prosthesis Infection
- Keywords
- 99mTc-Exametazime (HMPAO)-Labeled Leukocytes, suspected subdiaphragmatic vascular prosthesis infection, diagnosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Sep 2015
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 2 Sep 2015 (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.
Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis is often difficult (germs are found only in 50% of cases). Conventional imagery is often non-specific and difficult to interpret especially in early postoperative phase. Leukocytes isolated from the patient's blood are labeled with a radiopharmaceutical technetium 99mTc-HMPAO.
The aim of this study is to assess the overall diagnostic performance of scintigraphy (hybrid SPEC-CT) with labeled leucocytes in diagnosis of subdiaphragmatic vascular prothesis infection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 99mTc-Exametazime (HMPAO)-labeled leucocytes | Experimental | Biological: 99mTc-Exametazime (HMPAO)-labeled leukocytes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient of more than 18 years old
- Patient with a subdiaphragmatic vascular prosthesis
- Vascular prosthesis infection suspected with clinical (flow from the scare and/or local pain and/or erythema and/or persistent fever and/or bacteraemia) and/or biological (inflammatory syndrome : elevated C-reactive protein and/or erythrocyte sedimentation rate (ESR) and/or white blood cells increased) infection signs
- Patient willing to participate with a signed informed consent
- Patient covered by a healthcare insurance
Key exclusion criteria (8 listed)
- Pregnant women or of childbearing age without effective contraception
- Prosthesis limited to a bare stent.
- Patient who has been committed to an institution by legal or regulatory order
- Contraindications for labeled leukocytes scintigraphy realization :
- Restlessness, inability to keep still lie at least 1 hour
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 |
|---|---|---|
| 99mTc-Exametazime (HMPAO)-labeled leukocytesHybrid tomoscintigraphy with labeled leucocytes for patients with suspected vascular prosthesis infection | Biological | 99mTc-Exametazime (HMPAO)-labeled leucocytes |
Primary outcome
Percentage of patients correctly classified by interpreting scintigraphy for the diagnosis of vascular prosthesis infection. The percentage of patients correctly classified is assessed comparing with the diagnostic established by the expert committee.
Time frame: One year after inclusion when vascular prosthesis infection is suspected and hybrid SPEC-CT with labeled leukocytes has been performed.
A visual analysis of scintigraphy for diagnosing vascular prosthesis infection. Scintigraphy is considered positive if at least one abnormal localization is seen at vascular prosthesis and if intensity is increasing over time on 20-24h delayed images.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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.
HERVE RAKOTONIRINA, Dr principal investigator
University Hospital, Angers
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 99mTc-Exametazime (HMPAO)-labeled leukocytes in people with Vascular Prosthesis Infection, run by University Hospital, Angers at 3 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 5 inclusion and 8 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 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 HERVE RAKOTONIRINA, Dr (+33(0)241353412, HeRakotonirina@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients correctly classified by interpreting scintigraphy for the diagnosis of vascular prosthesis infection. The percentage of patients correctly classified is assessed comparing with the diagnostic established by the expert committee. (time frame: One year after inclusion when vascular prosthesis infection is suspected and hybrid SPEC-CT with labeled leukocytes has been performed.). 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 7 Mar 2019.