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

Endocarditis Clinical Trial

— PLEIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03112356
• Other study ID #: 69HCL16_0728
• Status: Recruiting
• Phase: Phase 4
• First received: March 24, 2017
• Last updated: June 19, 2017
• Start date: June 14, 2017
• Est. completion date: October 14, 2018

Study information

• Verified date: June 2017
• Source: Hospices Civils de Lyon
• Contact: Bastien GREGOIRE, MD
• Phone: 472357629
• Email: bastien.gregoire[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 14, 2018
• Est. primary completion date: October 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Endocarditis
• Infection

Intervention

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)

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)