Pilot study using Fluorine-18 labeled leucocytes in diagnosing infections.

Recruiting

• Conditions: bacterial infection; fever without focus; 10004018

• Registration Number: NL-OMON34884
• Lead Sponsor: Isala Klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

-AGe > 18 yrs, and
-Informed consent, and
-Satisfies definition of group 1, 2 or 3:;Group 1: Suspected osteomyelitis or septic arthritis in diabetic foot patient
Group 2: patients with staphylococcus aureus bacteremia, proven by bloodculture
Group 3: restgroup, among which fever-of-unknown-origin

Exclusion Criteria

-Antibiotics use > 7 days and evident clinical response as a result
Leukopenia (affects sensitivity, too few cels for radiolabeling) < 2000 / mm3
Pregnancy
Lactation
Unable to tolerate blood collection and PET/CT

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1.Image quality<br /><br>2. Sensitivity and specificity of LeucoPET/CT in detecting infectious foci.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a</p><br>