The purpose of this study is to obtain an impression of the general image quality and clinical value of leucocyte PET/CT in visualizing infectious foci in the body.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1.Image quality
2. Sensitivity and specificity of LeucoPET/CT in detecting infectious foci.
Secondary outcome
n.a
Background summary
Traditional leucocyte scintigraphy is a common and old procedure in detecting
infectious foci. Positron Emission Tomography (PET/CT) using fluorine-18
labeled leucocytes (Leuco PET/CT) is new method, that may be able to detect
infectious foci with a much greater resolution. Worldwide experience with this
method is still limited.
Study objective
The purpose of this study is to obtain an impression of the general image
quality and clinical value of leucocyte PET/CT in visualizing infectious foci
in the body.
Study design
This is a pilot study in 40 patients with a infectious clinical problem will
undergo Leuco PET/CT. This groups consists of 10 patients with a diabetic foot
(query osteomyelitis), 10 patients with a staphylococcus aureus bacteremia
(query location of septic emboli) and 20 patients with fever of unknown origin.
Image quality will be qualitatively assessed. Sensitivity in detecting
infectious foci will be calculated. As gold standard a composite reference
standard will be used, obtained by combining all clinical, biochemical,
bacteriological information as well as all imaging.
Study burden and risks
Patient burden
-time investment of 4-5 hours, including 2 wait periodes, consisting of a short
visit for blood draw (15-30 min), a short visit for reinjection of radiolabeled
leucocytes (15 min), and a longer visit to undergo the PET/CT scan (< 1 hr)
-radiation dose of approx. 8 mSv
-laying motionless in supine position for PET/CT
There are no specific risks associated with this study.
Dr van Heesweg 2
8000 BM Zwolle
NL
Dr van Heesweg 2
8000 BM Zwolle
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31293.075.10 |