Clinical trial NCT02682732: Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia
Official title: Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leukemia, Myeloid, Acute
Keywords: Acute Myeloid Leukemia
PET/CT Scan
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with heterogeneous (positron-emission tomography) PET/CT activity before induction chemotherapy
timeFrame: Up to 3 years
Secondary outcomes:
measure: Number of patients with residual (positron-emission tomography) PET/CT activity following induction chemotherapy
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital and Cancer Center
state: Ontario
Study officials:
affiliation: McMaster University
name: Mickie Bhatia, PhD
role: STUDY_DIRECTOR
References: