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

M.D. Anderson Cancer Center

Status and phase

Active, not recruiting

Phase 1

Conditions

Acute Promyelocytic Leukemia With PML-RARA

Acute Myeloid Leukemia

Treatments

Procedure: Three-Dimensional Spoiled Gradient MRI

Radiation: Fludeoxyglucose F-18

Procedure: Positron Emission Tomography

Procedure: Magnetic Resonance Imaging

Procedure: Computed Tomography

Drug: Gadolinium

Procedure: Diffusion Weighted Imaging

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02390635

2014-0616

NCI-2015-00525 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

77 participants in 1 patient group

Diagnostic (18F-FDG PET/CT, whole body PET/MRI)

Experimental group

Description:

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.