Recruiting

Molecular Imaging

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT02682732

Conditions

Leukemia, Myeloid, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FDG-PET/CT guided bone marrow sampling

Study Details

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.

Conditions

Leukemia, Myeloid, Acute

Study ID

NCT02682732

Start date

Apr, 2016

Status verified date

Feb, 2018

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Mohammed Almakadi, MBBS

905-525-9140almakams@mcmaster.ca

Locations

Juravinski Hospital and Cancer Center

Recruiting

Hamilton, Ontario, Canada

Contacts

Mohammed Almakadi, MBBS

almakams@mcmaster.ca

Principal Investigator:

Mohammed Almakadi, MBBS

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Feb 22, 2018

Last verified

Feb, 2018

Keywords

  • Acute Myeloid Leukemia
  • PET/CT Scan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2018-02-22.