Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia

Leukemia, Myeloid, Acute Clinical Trial

Official title:

Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02682732
• Other study ID #: NIF-15378
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2016
• Last updated: February 20, 2018
• Start date: April 2016
• Est. completion date: December 2020

Study information

• Verified date: February 2018
• Source: Hamilton Health Sciences Corporation
• Contact: Mohammed Almakadi, MBBS
• Phone: 905-525-9140
• Email: almakams[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Procedure:
• FDG-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.

Locations

Country	Name	City	State
Canada	Juravinski Hospital and Cancer Center	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with heterogeneous (positron-emission tomography) PET/CT activity before induction chemotherapy		Up to 3 years
Secondary	Number of patients with residual (positron-emission tomography) PET/CT activity following induction chemotherapy		Up to 3 years

External Links

•   Acute Myeloid Leukemia
•   PET Scan