An interventional study of FDG-PET/CT and Conventional CT in Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Haematopoietic Stem Cell Transplant, Autologous, sponsored by Peter MacCallum Cancer Centre, Australia. Completed at 2 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-17.
Sponsored by Peter MacCallum Cancer Centre, Australia · Not applicable, Interventional, and Diagnostic
Patients with acute leukaemia requiring induction or consolidation chemotherapy and those requiring a haematopoietic stem cell transplant are at high risk of fever and infection when they have low white cell counts (neutropenic fever). The causes of neutropenic fever are frequently unknown and patients are treated with broad antibiotics, without a clear target to what is being treated.
This study will prospectively enroll patients who are receiving chemotherapy for acute leukaemia or for a stem cell transplant and compare the diagnostic utility of bacterial and fungal PCR performed directly off blood drawn, to the standard blood culture. Patients who have persistent fever after 72 hours of antibiotics will then be randomized to have either the interventional scan (PET/CT) or the conventional scan (standard CT) to look for a source of infection. Diagnostic yield, change in management and outcomes will be compared between arms.
Exclusion Criteria:
Participants with persistent febrile neutropenia after 72 hours of onset who are randomized to this arm will have an FDG-PET/CT performed to look for source of fever.
Diagnostic Test: FDG-PET/CT
Participants with persistent febrile neutropenia after 72 hours of onset who are randomized to this arm will have a conventional CT (HRCT chest and sinuses +/- other regions as per clinician's discretion) performed to look for source of fever.
Diagnostic Test: Conventional CT
FDG-PET performed with low dose CT
Also known as: PET/CT
HRCT and CT of sinuses +/- other regions as per clinician's discretion
Change in management following randomized scan
Defined as: * referral for targeted sampling, referral for surgery * change in antimicrobial therapy * removal of a central line
Time frame: Within 48 hours of scan result
Proportion of participants with a cause of neutropenic fever
The proportion of participants in each arm where there is a confirmed cause of neutropenic fever
Time frame: By hospital discharge, an average of 4 weeks
Hospital length of stay
The duration (in days) of hospital length of stay for the episode in which neutropenic fever occurred
Time frame: By hospital discharge, an average of 4 weeks
Costs of hospital care
The overall cost of the inpatient stay for the episode in which neutropenic fever occurred
Time frame: By hospital discharge, an average of 4 weeks
Proportion admitted to intensive care
The proportion of patients in each arm who were admitted to intensive care during their admission in which neutropenic fever occurred
Time frame: By hospital discharge, an average of 4 weeks
In hospital mortality
The proportion of patients per arm who have passed away during the admission in which neutropenic fever occurred
Time frame: By hospital discharge, an average of 4 weeks
6 month mortality
The proportion of patients per arm who have passed away 6 months post study entry
Time frame: 6 months from study entry
Plan to share: Undecided
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Peter MacCallum Cancer Centre, Australia