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

Civil Hospices of Lyon

Status and phase: Unknown; Phase 4

Conditions: Endocarditis

Treatments: Drug: 99mTc-Leukoscan® scintigraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT03112356

69HCL16_0728

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

99mTc-Leukoscan® scintigraphy

Experimental group

Description:

Patients presenting a suspicions of infectious endocarditis on surgical materials and undergoing the 99mTc-Leukoscan® scintigraphy

Treatment:

Drug: 99mTc-Leukoscan® scintigraphy