Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-03 @ 8:26 AM
Study NCT ID:
NCT03112356
Status:
UNKNOWN
Last Update Posted:
2017-06-20
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials
Status:
UNKNOWN
Status Verified Date:
2017-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLEIM
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: