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

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia; Acute Promyelocytic Leukemia With PML-RARA
• Interventions: 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

• Registration Number: NCT02390635
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

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.

Study Timeline

• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-17
• Study Start: 2020-07-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-09-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)	Gadolinium	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.
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)	Fludeoxyglucose F-18	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.
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)	Computed Tomography	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.
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)	Diffusion Weighted Imaging	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.
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)	Three-Dimensional Spoiled Gradient MRI	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.
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)	Magnetic Resonance Imaging	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.
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)	Positron Emission Tomography	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States