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RecruitingPhase 1NCT02390635

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

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

77 participants

Start Date

Jul 15, 2020

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid LeukemiaAcute Promyelocytic Leukemia With PML-RARA

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria12

  • 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

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Interventions

PROCEDUREComputed Tomography

Undergo 18F-FDG PET/CT

PROCEDUREDiffusion Weighted Imaging

Undergo whole body PET/MRI

RADIATIONFludeoxyglucose F-18

Undergo 18F-FDG PET/CT

DRUGGadolinium

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo whole body PET/MRI

PROCEDUREPositron Emission Tomography

Undergo 18F-FDG PET/CT and whole body PET/MRI

PROCEDUREThree-Dimensional Spoiled Gradient MRI

Undergo whole body PET/MRI

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT02390635

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