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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03112356

Acronym

PLEIM

Enrollment

Registered

2017-04-13

Start date

2017-06-14

Completion date

2018-10-14

Last updated

2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocarditis

Keywords

infectious endocarditis, prosthetic valve infection, implantable cardiac device infection, 99mTc-Leukoscan® scintigraphy

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.

Interventions

DRUG99mTc-Leukoscan® scintigraphy

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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

France

Contacts

Primary ContactBastien GREGOIRE, MD

bastien.gregoire@chu-lyon.fr472357629

Backup ContactNawele BOUBLAY

nawele.boublay@chu-lyon.fr427856302

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026