Objective: The primary objective of this pilot study is to compare FDG-PET-CT with HR-CT alone and to HR-CT and galactomannan test together for early diagnosing IFIs in neutropenic patients.
ID
Source
Brief title
Condition
- Haematological disorders NEC
- Fungal infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Has FDG-PET-CT additional value as imaging modality compared to the
HR-CT thorax? Are their specific imaging characteristics found on FDG-PET-CT in
relation to the 3 different described lesions found by HR-CT? Can FDG-PET-CT
also provide information about the extension of the known lesions, i.e. is the
halo sign on HR-CT involved in the infectious process or is it a sign of
decreased perfusion due to infarction?
* Can FDG-PET-CT detect enlarged and/or positive lymph nodes and what is the
meaning of these lymph nodes in relation to prognosis or GM detection?
* Is FDG-PET-CT able to find additional infectious lesions that are not visible
on HR-CT of the thorax? Can FDG-PET-CT detect smaller lesions than HR-CT by its
metabolic positivity and is there a relation between the total amount of
metabolic positivity of lesions (mean SUV times area of positivity) and
galactomannan positivity, which is a parameter of activity and/or invasiveness
of aspergillosis?
* Is FDG-PET-CT able to find additional infectious lesions that are not visible
on HR-CT of the thorax because they are found outside the thorax? Sometimes IFI
are found in the sinussen or gut or brain or combinations of these
localisations.
Secondary outcome
Not applicable
Background summary
Rationale: Invasive fungal infections (IFIs) can be life threatening,
especially in prolonged neutropenic patients. The overall mortality in this
group has decreased from 60-80% in the past to 30-40% today because of better
diagnostics and antifungals. It is essential to diagnose IFIs and start the
right treatment as soon as possible to increase survival rates of the patients.
Nowadays, HR-CT as imaging technique and galactomannan (GM)-test (Elisa) in
blood and fluid (obtained by broncho-alveolar lavage) are together considered
the *gold standard* for diagnosing IFIs, but both techniques have their
limitations and provide probable diagnosis at best. It is therefore of
invaluable importance to have another non-invasive test which can provide a
higher sensitivity and specificity for diagnosing these IFIs. 18F-FDG-PET, and
even better the combined PET-CT scan (which correlates anatomic with
pathophysiologic imaging) might be this important non-invasive imaging
technique with better characteristics to early diagnose IFIs.
Study objective
Objective: The primary objective of this pilot study is to compare FDG-PET-CT
with HR-CT alone and to HR-CT and galactomannan test together for early
diagnosing IFIs in neutropenic patients.
Study design
Study design: All twelve patients will undergo, within 48 hours of the HR-CT,
an FDG-PET-CT scan (low dose CT) on the mCT (Siemens) camera at the Department
of Nuclear Medicine and Molecular Imaging. The FDG-PET-CT will be evaluated
qualitatively and quantitatively by calculation of the maximal Standardized
Uptake Value (SUVmax). These quantitative parameters will be correlated with
the results of the galactomannan-tests. Treatment schedule will be similar as
normal treatment procedures, i.e. treatment regimen will not depend on the
results of the FDG-PET-CT. We hope to find that FDG-PET-CT is able to localize
IFI with more accuracy and give us pathognomic signs in this group of patients
for having an IFI. This pilot study can form the basis for larger patient
studies to see if FDG-PET-CT is able to detect IFI with greater sensitivity and
specificity and eventually replace the invasive galactomannan-test by
broncho-alveolar lavage.
Study burden and risks
Radiation dose considerations:
Use of positron emitting radionuclides means exposure to ionizing radiation.
Because of the potential hazard of radiation, guidelines for the exposure of
healthy volunteers and patients are specified in *Besluit Stralingsbescherming
(BS 2000), artikel 60, Staatsblad 2001, 397*, according to the guidelines of
the International Commission on Radiological Protection.
The radiation exposure of one FDG-PET-CT (low dose CT) is approximately 9.1 mSv
(7.6 mSv for FDG-PET and 1.5 mSv for low dose CT). This complies with category
IIb, IRCP 62.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Adult patients (age > 18 years) with a hematologic disease who probably or possibly have an IFI. That means:
* Prolonged (or expected prolonged) neutropenia (leukocyte count < 1,0x109 or granulocyte count < 0,5x109, or leukocyte count < 1,5x109 or granulocyte count < 1,0x109 and decreasing due to chemotherapy), and
* Axillary temperature * 38, 5°C, not reacting on treatment with wide-spectrum antibacterial drugs for 72 hours, and
* A positive HR-CT scan, suspect for an IFI and
o A positive galactomannan-test in serum or fluid acquired by BAL, or positive in both materials (N<=6)
o A negative galactomannan-test GM in both serum and BAL fluid (N<=6)
Exclusion criteria
* Patients with age < 18 years
* Female patients who are pregnant
* Patients with claustrophobia or other reasons that make the scanning impossible, such as unable to lie still, need of oxygen, and so on.
* Patients who are hemodynamically instable
* (Pre)terminal patients for which the investigation is too burdensome
* Patients who may clinically not be able to undergo the study
* Patients without prolonged or expected prolonged immunocompromised condition (less than 14 days)
* Patients without positive signs of IFI on HR-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 | NL36625.042.11 |