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

ConditionsAcute Myeloid Leukemia Acute Promyelocytic Leukemia With PML-RARA

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Computed Tomography
Procedure/Surgery
Undergo 18F-FDG PET/CT
Diffusion Weighted Imaging
Procedure/Surgery
Undergo whole body PET/MRI
Fludeoxyglucose F-18
Radiation
Undergo 18F-FDG PET/CT
Gadolinium
Drug
Given IV
Magnetic Resonance Imaging
Procedure/Surgery
Undergo whole body PET/MRI
Positron Emission Tomography
Procedure/Surgery
Undergo 18F-FDG PET/CT and whole body PET/MRI
Three-Dimensional Spoiled Gradient MRI
Procedure/Surgery
Undergo whole body PET/MRI

Treatment groups

77 Participants

are divided into 1 treatment group

Group A: Diagnostic (18F-FDG PET/CT, whole body PET/MRI)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

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.

Time frame

At time of imaging

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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