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

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ClinicalTrials.gov Identifier: NCT03112356
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Endocarditis Drug: 99mTc-Leukoscan® scintigraphy Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : October 14, 2018
Estimated Study Completion Date : October 14, 2018

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Presence or not of infectious endocarditis on surgical materials [ Time Frame: 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).



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112356


Contacts
Contact: Bastien GREGOIRE, MD 472357629 ext +33 bastien.gregoire@chu-lyon.fr
Contact: Nawele BOUBLAY 427856302 ext +33 nawele.boublay@chu-lyon.fr

Locations
France
Hospices Civils de Lyon Recruiting
Bron, France, 69500
Contact: Bastien GREGOIRE, MD    472357629 ext +33    bastien.gregoire@chu-lyon.fr   
Contact: Nawele BOUBLAY    427856302 ext +33    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         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Bastien GREGOIRE, MD Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03112356     History of Changes
Other Study ID Numbers: 69HCL16_0728
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
infectious endocarditis
prosthetic valve infection
implantable cardiac device infection
99mTc-Leukoscan® scintigraphy

Additional relevant MeSH terms:
Communicable Diseases
Infection
Endocarditis
Endocarditis, Subacute Bacterial
Endocarditis, Bacterial
Bacterial Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Cardiovascular Infections
Heart Diseases
Cardiovascular Diseases