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 : Unknown
Verified June 2017 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : April 13, 2017
Last Update Posted : June 20, 2017
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)|
|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|
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)
- 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).
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
|Contact: Bastien GREGOIRE, MD||472357629 ext +firstname.lastname@example.org|
|Contact: Nawele BOUBLAY||427856302 ext +email@example.com|
|Hospices Civils de Lyon||Recruiting|
|Bron, France, 69500|
|Contact: Bastien GREGOIRE, MD 472357629 ext +33 firstname.lastname@example.org|
|Contact: Nawele BOUBLAY 427856302 ext +33 email@example.com|
|Principal Investigator: Bastien GREGOIRE, MD|
|Sub-Investigator: François DELAHAYE, MD|
|Sub-Investigator: Caroline MOREAU, MD|
|Sub-Investigator: Géraldine PINAJOMIR, MD|
|Principal Investigator:||Bastien GREGOIRE, MD||Hospices Civils de Lyon|