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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-14

Study Completion Date

2018-10-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Endocarditis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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99mTc-Leukoscan® scintigraphy

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

Group Type EXPERIMENTAL

99mTc-Leukoscan® scintigraphy

Intervention Type DRUG

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)

Interventions

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99mTc-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)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No