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Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia

Primary Purpose

Leukemia, Myeloid, Acute

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

FDG-PET/CT guided bone marrow sampling

About this trial

This is an interventional diagnostic trial for Leukemia, Myeloid, Acute focused on measuring Acute Myeloid Leukemia, PET/CT Scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Juravinski Hospital and Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FDG-PET/CT

Arm Description

(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.

Outcomes

Primary Outcome Measures

Number of patients with heterogeneous (positron-emission tomography) PET/CT activity before induction chemotherapy

Secondary Outcome Measures

Number of patients with residual (positron-emission tomography) PET/CT activity following induction chemotherapy

Full Information

NCT ID

NCT02682732

First Posted

February 3, 2016

Last Updated

February 20, 2018

Sponsor

Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02682732

Brief Title

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

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Myeloid, Acute

Keywords

Acute Myeloid Leukemia, PET/CT Scan

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FDG-PET/CT

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

FDG-PET/CT guided bone marrow sampling

Intervention Description

(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.

Primary Outcome Measure Information:

Title

Number of patients with heterogeneous (positron-emission tomography) PET/CT activity before induction chemotherapy

Time Frame

Up to 3 years

Secondary Outcome Measure Information:

Title

Number of patients with residual (positron-emission tomography) PET/CT activity following induction chemotherapy

Time Frame

Up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammed Almakadi, MBBS

Phone

905-525-9140

Ext

21872

almakams@mcmaster.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mickie Bhatia, PhD

Organizational Affiliation

McMaster University

Official's Role

Study Director

Facility Information:

Facility Name

Juravinski Hospital and Cancer Center

City

Hamilton

State/Province

Ontario

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohammed Almakadi, MBBS

almakams@mcmaster.ca

First Name & Middle Initial & Last Name & Degree

Mohammed Almakadi, MBBS

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The data will be shared after the study is completed

Links:

URL

https://www.nlm.nih.gov/medlineplus/acutemyeloidleukemia.html

Description

Acute Myeloid Leukemia

URL

https://www.nlm.nih.gov/medlineplus/ency/article/003827.htm

Description

PET Scan

Learn more about this trial

Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia

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