Informations générales (source: ClinicalTrials.gov)
The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials (PLEIM)
Interventional
Phase 4
Hospices Civils de Lyon (Voir sur ClinicalTrials)
juin 2017
octobre 2018
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hospices Civils de Lyon - 69500 - Bron - France | Bastien GREGOIRE, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Male or female subjects aged > 21 years
- Patients presenting a suspicions of infectious endocarditis on surgical materials
- Written informed consent
- Male or female subjects aged > 21 years
- Patients presenting a suspicions of infectious endocarditis on surgical materials
- Written informed consent
- 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)