The expectation is that FDG-PET demonstrates or excludes infectious complications earlier than current practice, resulting in more efficient use of other diagnostic methods and therapy. Besides early detection and treatment of invasive fungal…
ID
Source
Brief title
Condition
- Other condition
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
- Fungal infectious disorders
Synonym
Health condition
febriele neutropenie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In the analysis the correlation between clinical defined infection (CDI) or
microbiologically defined infection (MDI) and abnormalities on FDG-PET will be
studied.
Secondary outcome
NA
Background summary
Fever during chemotherapeutic induced neutropenia (febrile neutropenia) is a
frequent problem and is considered to be a sign of possible urgent and life
threatening infectious complications of hemato-oncologic treatment until the
opposite has been proven. In 30-50% of patients infection can be pointed out as
the cause of fever. During persistent fever in spite of broad-spectrum
antibiotic treatment antifunal therapy aimed at invasive Candida or
Aspergillus infections is added.
Recent studies in our own hospital recently showed that febrile neutropenia is
not a specific indicator of infection. The hypothesis is that increase in
C-reactive protein and fever initially is caused by inflammation of mucosa of
the digestive tract in reaction to cytotoxic treatment of haematological
malignancies. Infection subsequently results from mucosal barrier injury.
Since FDG accumulates in infectious foci, FDG-PET seems to be an promising
diagnostic technique in these patients. Studies in our own hospital
investigating the value of FDG-PET in solving fever of unknown origin and
diagnosing metastatic infectious disease clarified that abnormalities on PET
often prejudge anatomical disturbances seen on conventional radiological
techniques. The presence of a combined PET/CT-scan facilitates the possibility
to combine FDG-PET and the currently used thoracic high resolution CT-scanning
in one session when invasive fungal infection is suspected.
Study objective
The expectation is that FDG-PET demonstrates or excludes infectious
complications earlier than current practice, resulting in more efficient use of
other diagnostic methods and therapy. Besides early detection and treatment of
invasive fungal infections positively influences treatment outcome.
Study design
In a prospective, descriptive analysis the capability of FDG-PET to delineate a
localized inflammatory process causing febrile neutropenia earlier than current
daily practice is investigated. FDG-PET is therefore added to the regular
diagnostic work-up.
Study burden and risks
A maximum of 2 PET-scans per person will be made, at a minimal 3 day interval.
No adverse effects are to be expected. Potential relevant abnormalities on PET
will be confirmed as much as possible using current diagnostic techniques.
postbus 9101
6500HB Nijmegen
Nederland
postbus 9101
6500HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
- admission and treatment at the department of hematology because of a hematological malignancy
- expected duration of neutropenia >7 days;and any of the following:
* C-reactive proteïn > 50 mg/l
* febrile neutropenia > 3-4 days despite aimed empirical or aimed antibiotic therapy
* persistant bacteraemia with coagulase negative Staphylococci
* pulmonary HRCT inidicated because of suspected pulmonary Aspergillosis
Exclusion criteria
- hemodynamic instablility
- diabetus millitus in which insulin has to be administered within 4 hours of the PET-scan either bloodglucose levels exceed 15 mmol.l
- pregnancy or lactation
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 | NL11231.091.06 |