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

NCT03112356 | Unknown Phase 4

• 1 other identifier: 69HCL16_0728
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Endocarditis

Keywords

infectious endocarditis; prosthetic valve infection; implantable cardiac device infection; 99mTc-Leukoscan® scintigraphy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

99mTc-Leukoscan® scintigraphy

EXPERIMENTAL

Patients presenting a suspicions of infectious endocarditis on surgical materials and undergoing the 99mTc-Leukoscan® scintigraphy

Drug: 99mTc-Leukoscan® scintigraphy

Interventions

99mTc-Leukoscan® scintigraphy DRUG

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)

99mTc-Leukoscan® scintigraphy

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged \> 21 years
• Patients presenting a suspicions of infectious endocarditis on surgical materials
• Written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Endocarditis; Endocarditis, Subacute Bacterial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Endocarditis, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Cardiovascular Infections

Study Officials

• Bastien GREGOIRE, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bastien GREGOIRE, MD

CONTACT

472357629; bastien.gregoire@chu-lyon.fr

Nawele BOUBLAY

CONTACT

427856302; nawele.boublay@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 13, 2017
• Study Start: June 14, 2017
• Primary Completion: October 14, 2018
• Study Completion: October 14, 2018
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)