Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia

February 20, 2018 updated by: Mohammed Almakadi, Hamilton Health Sciences Corporation
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • Juravinski Hospital and Cancer Center
        • Contact:
        • Principal Investigator:
          • Mohammed Almakadi, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FDG-PET/CT
(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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with heterogeneous (positron-emission tomography) PET/CT activity before induction chemotherapy
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with residual (positron-emission tomography) PET/CT activity following induction chemotherapy
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Investigators

  • Study Director: Mickie Bhatia, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIF-15378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data will be shared after the study is completed

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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