To investigate if ultra low-dose chest CT may be a better diagnostic tool than chest X-ray on day 1 of febrile neutropenia. Imaging results will be compared with a consensus diagnosis on the cause of febrile neutropenia made by an expert panel.…
ID
Source
Brief title
Condition
- White blood cell disorders
- Immunodeficiency syndromes
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are chest X-ray, ultra low-dose CT, HRCT and
consensus diagnosis. The main endpoint is sensitivity of imaging test for a
pulmonary focus of febrile neutropenia as established by consensus diagnosis.
Secondary outcome
Secondary study parameters/endpoints are routinely obtained serum galactomannan
test, bronchoalveolar lavage (BAL) and blood tests.
Background summary
Standard radiological work up for detection of pulmonary infection in febrile
neutropenia is done with chest X-ray. But the sensitivity of this test is low,
leading to diagnostic insecurity and therefore broad testing of infection
possibilities and broad spectrum antibiotic use. We expect that ultra low-dose
chest computed tomography (CT) with iterative reconstruction (IR) can detect
pulmonary sites of febrile neutropenia 80% more often than routine chest X-ray.
Furthermore, we aim to obtain pilot data for the performance of ultra low-dose
chest CT on day 5 and week 6 in the detection of pulmonary invasive mould
infections compared to the routine-dose high resolution computed tomography
(HRCT).
Study objective
To investigate if ultra low-dose chest CT may be a better diagnostic tool than
chest X-ray on day 1 of febrile neutropenia. Imaging results will be compared
with a consensus diagnosis on the cause of febrile neutropenia made by an
expert panel.
Thereby, a pilot-study to investigate if ultra low-dose chest CT is comparable
to HRCT in the characterization of mould infection abnormalities on day 5 and
week 6.
Study design
Prospective diagnostic mono-center study.
Study burden and risks
The patient does not have benefit from participating in this study and will
receive routine care. For research purposes additional ultra low-dose CT scans
are obtained. The additional ultra low-dose CT scans will be analysed after the
study has been completed. This study may contribute to a better diagnostic
procedure in future patients with febrile neutropenia, limit extensive testing
searching for the cause of fever, creates the possibility for more focussed
treatment and possibly earlier detection of mould infections. The additional
radiation dose on day 1 is 0.25-0.5 mSv (ultra low-dose chest CT) and for the
subjects with persistent fever on day 5 and week 6 if applicable 0.25-0.5 mSv
(ultra low-dose chest CT), therefore the additional radiation dose is 0.75-1.5
mSv per episode. In comparison, the background radiation in The Netherlands is
approximately 2.4 mSv per year. The additional CT visit on day 1 will be
combined with the routine chest X-ray and will take the patients an additional
15 - 30 minutes. If a patient has an indication for a routine CT on day 5 and
week 6, the additional ultra low-dose image acquisitions will be obtained in
the same session as the routine CT and will take an additional minute.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Patients >= 18 years
- Neutropenia due to chemotherapy given for haematological disease or conditioning regimen for autologous or allogenic stem cell transplantation. Neutropenia is defined as absolute neutrophil count < 0.5 x 109 cells/L or a count of < 1.0 x 109 cells/L with a predicted decrease to < 0.5 x 109 cells/L within 3 days
- Chest X-ray made in the diagnostic work up on day 1 on the radiology department
- Fever (temperature > 38.3°C once or >= 38.0 °C longer than 1 hour) not related to administration of blood products or medication
- Written informed consent
Exclusion criteria
- Patients with a known focus of infection unrelated to the lower respiratory tract
- Patients with a history of probable or proven invasive mould infection without a clinically available normalized chest CT and who use antimycotics
- Previous participation in the study
- Concomitant participation in a study in which the subject is exposed to X-rays
- Chest X-ray made on ward (*bed-thorax*)
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 | NL41415.041.12 |