Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia

Not Applicable

• Conditions: Leukemia, Myeloid, Acute
• Interventions: Procedure: FDG-PET/CT guided bone marrow sampling

• Registration Number: NCT02682732
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-15
• Study Start: 2016-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FDG-PET/CT	FDG-PET/CT guided bone marrow sampling	(Fluorodeoxyglucose positron-emission tomography) FDG-PET/CT guided bone marrow sampling will be performed at diagnosis and at the end of induction chemotherapy (like cytarabine and daunorubicin). Then, patients will be followed to assess their response, and imaging-guided bone marrow sampling will be repeated in the likely event of disease relapse.

Primary Outcome Measures

Name	Time	Method
Number of patients with heterogeneous (positron-emission tomography) PET/CT activity before induction chemotherapy	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Number of patients with residual (positron-emission tomography) PET/CT activity following induction chemotherapy	Up to 3 years

Trial Locations

Locations (1)

Juravinski Hospital and Cancer Center; 🇨🇦 Hamilton, Ontario, Canada