Acute Myeloid Leukemia, Acute Promyelocytic Leukemia With PML-RARA
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo 18F-FDG PET/CT
PROCEDUREDiffusion Weighted Imaging
Undergo whole body PET/MRI
RADIATIONFludeoxyglucose F-18
Undergo 18F-FDG PET/CT
DRUGGadolinium
Given IV
PROCEDUREMagnetic Resonance Imaging
Undergo whole body PET/MRI
PROCEDUREPositron Emission Tomography
Undergo 18F-FDG PET/CT and whole body PET/MRI
PROCEDUREThree-Dimensional Spoiled Gradient MRI
Undergo whole body PET/MRI
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed