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

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.

• Computed Tomography (Procedure), also known as CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography: Undergo 18F-FDG PET/CT
• Diffusion Weighted Imaging (Procedure), also known as Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI, DW-MRI, DWI, DWI MRI, DWI-MRI, MR Diffusion-Weighted Imaging: Undergo whole body PET/MRI
• Fludeoxyglucose F-18 (Radiation), also known as 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18: Undergo 18F-FDG PET/CT
• Gadolinium (Drug), also known as Gd: Given IV
• Magnetic Resonance Imaging (Procedure), also known as Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging: Undergo whole body PET/MRI
• Positron Emission Tomography (Procedure), also known as Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging: Undergo 18F-FDG PET/CT and whole body PET/MRI
• Three-Dimensional Spoiled Gradient MRI (Procedure), also known as 3-Dimensional Fast Spoiled Gradient, 3D Fast Spoiled Gradient Recalled MRI, 3D FSPGR, 3DFSPGR, FSPGR, FSPGR MRI, SPGR, SPGR MRI, Three-Dimensional Spoiled Gradient-Echo MR: Undergo whole body PET/MRI

Primary outcomes

• Incidence of extramedullary myeloid leukemia (EML) [At time of imaging]: Defined as increased fludeoxyglucose F-18 uptake on positron emission tomography (PET)/computed tomography and increased signal on T2 weighted imaging or diffusion weighted imaging and enhancement in soft tissue on whole body PET/magnetic resonance imaging. Estimates and 95% confidence intervals for the incidence of EML will be reported for each imaging modality based on the exact Clopper-Pearson method.

Sex: All, ages: 18 Years to any

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

• Dawid Schellingerhout, Principal investigator, M.D. Anderson Cancer Center