Houston, Texas 77030


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients with newly diagnosed AML or acute promyelocytic leukemia (APL) - Women of child bearing potential with negative pregnancy test documented Exclusion Criteria: - Patients with contraindications to MR - Patients with a creatinine clearance less than 60 - 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 - Greater than 400 pounds in weight - Patients with uncontrolled diabetes


NCT ID:

NCT02390635


Primary Contact:

Principal Investigator
Vikas Kundra
M.D. Anderson Cancer Center

Vikas Kundra, MD, PHD
Phone: 713-745-2702
Email: vkundra@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Vikas Kundra
Phone: 713-745-2702
Email: vkundra@mdanderson.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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