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

Phase 4

• Conditions: Endocarditis
• Interventions: Drug: 99mTc-Leukoscan® scintigraphy

• Registration Number: NCT03112356
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Status Verified: 2017-06
• Study Start: 2017-06-14
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20
• Primary Completion: 2018-10-14
• Study Completion: 2018-10-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male or female subjects aged > 21 years
• Patients presenting a suspicions of infectious endocarditis on surgical materials
• Written informed consent

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Presence or not of infectious endocarditis on surgical materials	3 months (plus or minus 1 month)	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).

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Bron, France