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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Myeloid Leukemia, Acute Promyelocytic Leukemia With PML-RARA

Intervention / Treatment
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* Procedure: Computed Tomography
* Procedure: Diffusion Weighted Imaging
* Radiation: Fludeoxyglucose F-18
* Drug: Gadolinium
* Procedure: Magnetic Resonance Imaging
* Procedure: Positron Emission Tomography
* Procedure: Three-Dimensional Spoiled Gradient MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly diagnosed AML or acute promyelocytic leukemia (APL) Women of child bearing potential with negative pregnancy test documented Exclusion Criteria: Patients with contraindications to MR Patients with a creatinine clearance less than 60 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 Younger than 18 years Greater than 400 pounds in weight Patients with uncontrolled diabetes Cognitive impaired adults or prisoners will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (18F-FDG PET/CT, whole body PET/MRI)<br>Patients receive gadolinium IV and undergo whole body PET/MRI comprising diffusion weighted imaging and 3D FSPGR-DE with and without fiducial markers. Patients then undergo 18F-FDG PET/CT before start treatment for acute myeloid leukemia. | Procedure: Computed Tomography<br>* Undergo 18F-FDG PET/CT<br>* Other names: tomography;Procedure: Diffusion Weighted Imaging<br>* Undergo whole body PET/MRI<br>* Other names: MR Diffusion-Weighted Imaging;Radiation: Fludeoxyglucose F-18<br>* Undergo 18F-FDG PET/CT<br>* Other names: Fluorodeoxyglucose F18;Drug: Gadolinium<br>* Given IV<br>* Other names: Gd;Procedure: Magnetic Resonance Imaging<br>* Undergo whole body PET/MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Positron Emission Tomography<br>* Undergo 18F-FDG PET/CT and whole body PET/MRI<br>* Other names: proton magnetic resonance spectroscopic imaging;Procedure: Three-Dimensional Spoiled Gradient MRI<br>* Undergo whole body PET/MRI<br>* Other names: Three-Dimensional Spoiled Gradient-Echo MR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of extramedullary myeloid leukemia (EML) | 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. | At time of imaging |