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

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.

Study Overview

• Status: Unknown
• Conditions: Endocarditis
• Intervention / Treatment: Drug: 99mTc-Leukoscan® scintigraphy

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bastien GREGOIRE, MD; Phone Number: +33 472357629; Email: bastien.gregoire@chu-lyon.fr
• Study Contact Backup: Name: Nawele BOUBLAY; Phone Number: +33 427856302; Email: nawele.boublay@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Bastien GREGOIRE, MD; Phone Number: +33 472357629; Email: bastien.gregoire@chu-lyon.fr
    • Contact: Nawele BOUBLAY; Phone Number: +33 427856302; Email: nawele.boublay@chu-lyon.fr
    • Principal Investigator: Bastien GREGOIRE, MD
    • Sub-Investigator: François DELAHAYE, MD
    • Sub-Investigator: Caroline MOREAU, MD
    • Sub-Investigator: Géraldine PINAJOMIR, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 99mTc-Leukoscan® scintigraphy; Patients presenting a suspicions of infectious endocarditis on surgical materials and undergoing the 99mTc-Leukoscan® scintigraphy	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or not of infectious endocarditis on surgical materials	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).	3 months (plus or minus 1 month)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Bastien GREGOIRE, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Anticipated): October 14, 2018
• Study Completion (Anticipated): October 14, 2018

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: infectious endocarditis; prosthetic valve infection; implantable cardiac device infection; 99mTc-Leukoscan® scintigraphy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Cardiovascular Infections; Endocarditis, Bacterial; Infections; Communicable Diseases; Endocarditis; Endocarditis, Subacute Bacterial
• Other Study ID Numbers: 69HCL16_0728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No