NCT02390635

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Acute Promyelocytic Leukemia With PML-RARA

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo 18F-FDG PET/CT
PROCEDURE	Diffusion Weighted Imaging	Undergo whole body PET/MRI
RADIATION	Fludeoxyglucose F-18	Undergo 18F-FDG PET/CT
DRUG	Gadolinium	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo whole body PET/MRI
PROCEDURE	Positron Emission Tomography	Undergo 18F-FDG PET/CT and whole body PET/MRI
PROCEDURE	Three-Dimensional Spoiled Gradient MRI	Undergo whole body PET/MRI

Timeline

• Start date: 2020-07-15
• Primary completion: 2027-09-15
• Completion: 2027-09-15
• First posted: 2015-03-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study