The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials

Study Overview
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Brief Summary
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Infectious endocarditis is a serious pathology with difficult diagnosis especially on prosthetic valves or cardiac device because of the plurality of clinical presentations and the low sensitivity value of echocardiography in these patients. Despite a well validated indication for the detection of septic emboli, the value of FDG-PET for the detection of prosthetic valves or cardiac implantable device is still unclear especially because of frequent non-septic inflammatory processes. To improve the specificity value, the use of radio-labeled leukocytes scintigraphy is conventionally proposed. An alternative method is to label leukocytes in vivo with an anti-murin anti body fragment ( Sulesomab , Leukoscan®). This scintigraphy is regularly used in the investigation of osteomyelitis and has been proposed in infectious endocarditis. To knowledge of investigators, the value of Leukoscan® scintigraphy on prosthetic valve or cardiac device infection had not been studied.

Official Title
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The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials

Conditions
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Endocarditis

Intervention / Treatment
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* Drug: 99mTc-Leukoscan® scintigraphy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged > 21 years Patients presenting a suspicions of infectious endocarditis on surgical materials Written informed consent Exclusion Criteria: Patient with a history of exposure to murine antigens, particularly a patient who has already received a 99mTc-Leukoscan® scintigraphy Patients whose clinical condition requires prompt care, not allowing them to wait for the examination Pregnant or nursing (including pumping for storage and feeding) Patients under adapted antibiotic therapy for more than 15 days Deprivation of civil rights (curatorship, guardianship, safeguard of justice)

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 99mTc-Leukoscan® scintigraphy<br>Patients presenting a suspicions of infectious endocarditis on surgical materials and undergoing the 99mTc-Leukoscan® scintigraphy | Drug: 99mTc-Leukoscan® scintigraphy<br>* Gated single photon emission computed tomography with co-registered computer tomography (gated SPECT-CT) 6 hours and 24 hours after infusion of 99mTc-Leukoscan (1000 MBq)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or not of infectious endocarditis on surgical materials | The presence or not of infectious endocarditis on surgical materials will be measured using Duke's criteria of patients follow-up at 3 months (plus or minus 1 month). | 3 months (plus or minus 1 month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infectious endocarditis, prosthetic valve infection, implantable cardiac device infection, 99mTc-Leukoscan® scintigraphy