The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials (PLEIM)
Primary Purpose
Endocarditis
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
99mTc-Leukoscan® scintigraphy
Sponsored by
About this trial
This is an interventional diagnostic trial for Endocarditis focused on measuring infectious endocarditis, prosthetic valve infection, implantable cardiac device infection, 99mTc-Leukoscan® scintigraphy
Eligibility Criteria
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)
Sites / Locations
- Hospices Civils de LyonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
99mTc-Leukoscan® scintigraphy
Arm Description
Patients presenting a suspicions of infectious endocarditis on surgical materials and undergoing the 99mTc-Leukoscan® scintigraphy
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03112356
Brief Title
The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials
Acronym
PLEIM
Official Title
The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
October 14, 2018 (Anticipated)
Study Completion Date
October 14, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocarditis
Keywords
infectious endocarditis, prosthetic valve infection, implantable cardiac device infection, 99mTc-Leukoscan® scintigraphy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
99mTc-Leukoscan® scintigraphy
Arm Type
Experimental
Arm Description
Patients presenting a suspicions of infectious endocarditis on surgical materials and undergoing the 99mTc-Leukoscan® scintigraphy
Intervention Type
Drug
Intervention Name(s)
99mTc-Leukoscan® scintigraphy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Presence or not of infectious endocarditis on surgical materials
Description
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).
Time Frame
3 months (plus or minus 1 month)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bastien GREGOIRE, MD
Phone
472357629
Ext
+33
Email
bastien.gregoire@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nawele BOUBLAY
Phone
427856302
Ext
+33
Email
nawele.boublay@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bastien GREGOIRE, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bastien GREGOIRE, MD
Phone
472357629
Ext
+33
Email
bastien.gregoire@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Nawele BOUBLAY
Phone
427856302
Ext
+33
Email
nawele.boublay@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Bastien GREGOIRE, MD
First Name & Middle Initial & Last Name & Degree
François DELAHAYE, MD
First Name & Middle Initial & Last Name & Degree
Caroline MOREAU, MD
First Name & Middle Initial & Last Name & Degree
Géraldine PINAJOMIR, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials
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