drugset / Trial / NCT03112356

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

NCT03112356 ↗

Phase 4 Unknown 30 enrolled Hospices Civils de Lyon
NaSingle-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start
2017-06-14
Primary completion
2018-10-14
Completion
2018-10-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Sulesomab Monoclonal antibody 1000 mbq Intravenous

Indications