Leukemia, Myeloid, Acute
Conditions
Keywords
Acute Myeloid Leukemia, PET/CT Scan
Brief summary
The current understanding of acute myeloid leukemia (AML) is that one site of bone marrow (BM) sampling serves as a window that represents all AML cells distributed throughout the BM, an assumption that has yet to be questioned. Simulation in mice led to inconsistent representation of the full BM, which can incorrectly suggest the absence of leukemic cells. Positron-emission tomography (PET) scan can detect areas of high metabolic activity in the body using for instance a radioactive sugar. In one report, its use in human AML has provided proof-of-principle evidence of unequal distribution of AML cells in BM. Accordingly, the alternative hypothesis is to test if PET scan can demonstrate if BM geography can alter AML cells spread and home them as distinct areas rather than uniform spread as if they are distributed in liquid state.
Interventions
PROCEDUREFDG-PET/CT guided bone marrow sampling
(Fluorodeoxyglucose positron-emission tomography) FDG-PET/CT guided bone marrow sampling will be used to obtain two different samples from avid and dim bone marrow areas.
Sponsors
Hamilton Health Sciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New diagnosis of AML according to the WHO (World Health Organization) criteria
Exclusion criteria
* Prior malignancy, unless the patient has been disease-free for at least five years following curative intent therapy, with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease. * Acute promyelocytic leukemia (APL). * ECOG (Eastern Cooperative Oncology Group) performance status of 3 or more * Inadequate renal function (i.e., estimated GFR (glomerular filtration rate) \< 60 mL/min/1.73m2). * Inadequate hepatic function (i.e., serum bilirubin \> 1.5×ULN; AST (aspartate aminotransferase), ALT (alanine aminotransferase) and ALP (alkaline phosphatase) \> 2.5×ULN) * Presence of uncontrolled systemic fungal, bacterial, viral or other infections (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment). * Having any other severe concurrent disease or serious organ dysfunction that may place the patient at undue risk to receive induction therapy. * Pregnancy or lactating female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with heterogeneous (positron-emission tomography) PET/CT activity before induction chemotherapy | Up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with residual (positron-emission tomography) PET/CT activity following induction chemotherapy | Up to 3 years |
Countries
Canada
Contacts
Primary ContactMohammed Almakadi, MBBS
Outcome results
None listed