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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: M.D. Anderson Cancer Center • ClinicalTrials.gov ID: NCT02390635

Registry updated: 2026-10-13
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Description

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.

Interventions

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

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

Conditions

Acute Myeloid Leukemia Acute Promyelocytic Leukemia With PML-RARA

Locations

  • M D Anderson Cancer Center — Houston, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record