NCT02682732

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

3.7 years

First QC Date

February 3, 2016

Last Update Submit

February 20, 2018

Conditions

Leukemia, Myeloid, Acute

Keywords

Acute Myeloid LeukemiaPET/CT Scan

Outcome Measures

Primary Outcomes (1)

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

    Up to 3 years

Secondary Outcomes (1)

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

    Up to 3 years

Study Arms (1)

FDG-PET/CT

EXPERIMENTAL

(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

Interventions

FDG-PET/CT guided bone marrow samplingPROCEDURE

(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.

FDG-PET/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New diagnosis of AML according to the WHO (World Health Organization) criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juravinski Hospital and Cancer Center

Hamilton, Ontario, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Mickie Bhatia, PhD

    McMaster University

    STUDY DIRECTOR

Central Study Contacts

Mohammed Almakadi, MBBS

CONTACT

905-525-9140almakams@mcmaster.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MBBS, FRCP(C)

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 15, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

February 22, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

The data will be shared after the study is completed

Locations

CA(1)