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Trial record 2 of 596 for:    Recruiting, Not yet recruiting, Available Studies | "Leukemia, Myeloid, Acute"

Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT02682732
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mohammed Almakadi, 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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Procedure: FDG-PET/CT guided bone marrow sampling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia
Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


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.



Primary Outcome Measures :
  1. Number of patients with heterogeneous (positron-emission tomography) PET/CT activity before induction chemotherapy [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Number of patients with residual (positron-emission tomography) PET/CT activity following induction chemotherapy [ Time Frame: Up to 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682732


Contacts
Contact: Mohammed Almakadi, MBBS 905-525-9140 ext 21872 almakams@mcmaster.ca

Locations
Canada, Ontario
Juravinski Hospital and Cancer Center Recruiting
Hamilton, Ontario, Canada
Contact: Mohammed Almakadi, MBBS       almakams@mcmaster.ca   
Principal Investigator: Mohammed Almakadi, MBBS         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Study Director: Mickie Bhatia, PhD McMaster University

Additional Information:
Responsible Party: Mohammed Almakadi, MBBS, FRCP(C), Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02682732     History of Changes
Other Study ID Numbers: NIF-15378
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be shared after the study is completed

Keywords provided by Mohammed Almakadi, Hamilton Health Sciences Corporation:
Acute Myeloid Leukemia
PET/CT Scan

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms