Menu
Recruiting NCT02390635

PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase I Interventional Acute Myeloid Leukemia Acute Promyelocytic Leukemia With PML-RARA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computed Tomography, Diffusion Weighted Imaging, Fludeoxyglucose F-18, Gadolinium.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia, Acute Promyelocytic Leukemia With PML-RARA. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PET/MR, PET/CT and Whole Body MR in Newly Diagnosed Acute Myeloid Leukemia (AML)

Overview

This pilot phase I trial studies how well positron emission tomography (PET)/magnetic resonance imaging (MRI), fludeoxyglucose F-18 (18F-FDG) PET/computed tomography (CT), and whole body MRI work in finding extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia. Extramedullary myeloid leukemia is a type of cancer found outside of the bone marrow and can be hard to detect with routine bone marrow monitoring, such as bone marrow aspirations. Diagnostic procedures, such as PET/MRI, 18F-FDG PET/CT and whole body MRI, may help find and diagnose extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia.

Detailed description

PRIMARY OBJECTIVE:

I. To estimate the incidence of extramedullary myeloid leukemia (EML) in patients with newly diagnosed acute myeloid leukemia (AML), including acute promyelocytic leukemia (APL), by imaging criteria using PET/MR (magnetic resonance), whole body MR, and PET/CT.

SECONDARY OBJECTIVES:

I. To qualitatively and quantitatively assess PET/MR and PET/CR that will be performed with and without fiducial markers, and to correlate these findings with clinical outcomes of treatment response, relapse, and patterns of relapse.

II. Correlate findings of EML as in the primary objectives with clinical outcomes of treatment response, relapse, and patterns of relapse including location of relapse compared to site of EML.

OUTLINE:

Patients receive gadolinium intravenously (IV) and undergo whole body PET/MRI comprising diffusion weighted imaging and 3-dimentional (3D) fast spoiled gradient echo dual echo (FSPGR-DE) with and without fiducial markers. Patients then undergo 18F-FDG PET/CT before start treatment for acute myeloid leukemia.

After completion of study, patients are followed up periodically.

Interventions

  • Procedure Computed Tomography
    Undergo 18F-FDG PET/CT
  • Procedure Diffusion Weighted Imaging
    Undergo whole body PET/MRI
  • Radiation Fludeoxyglucose F-18
    Undergo 18F-FDG PET/CT
  • Drug Gadolinium
    Given IV
  • Procedure Magnetic Resonance Imaging
    Undergo whole body PET/MRI
  • Procedure Positron Emission Tomography
    Undergo 18F-FDG PET/CT and whole body PET/MRI
  • Procedure Three-Dimensional Spoiled Gradient MRI
    Undergo whole body PET/MRI

Primary outcome measures

  • Incidence of extramedullary myeloid leukemia (EML) [Time frame: At time of imaging]

Eligibility criteria

Inclusion criteria

  • Patients with newly diagnosed AML
  • Non-English speaking subjects will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consenting non-English speaking subjects.

Exclusion criteria

  • Patients with contraindications to MR
  • Patients with a known allergy to MR contrast agents
  • Uncontrollable claustrophobia
  • Recipients of more than minimal anti-leukemia treatment, with minimal treatment defined as: leukapheresis, hydroxyurea, or Cytarabine more than 1 g per square meter.
  • Patients with secondary or relapsed AML or APL should be excluded.
  • Patients with known extramedullary leukemia
  • Positive pregnancy test in a female of childbearing potential
  • Younger than 18 years
  • Greater than 400 pounds in weight
  • Patients with uncontrolled diabetes
  • Cognitive impaired adults or prisoners will be excluded
  • Estimated glomerular filtration rate (eGFR <30) will be excluded

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT02390635 · 2014-0616 · NCI-2015-00525 · 2014-0616

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗