Brief Title
PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia
Official Title
PET/MR, PET/CT and Whole Body MR in Newly Diagnosed Acute Myeloid Leukemia (AML)
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence of extramedullary myeloid leukemia (EML)
Condition
Acute Myeloid Leukemia
Intervention
Computed Tomography
Study Arms / Comparison Groups
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
55
Start Date
May 2, 2016
Completion Date
May 31, 2021
Primary Completion Date
May 31, 2021
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Vikas Kundra, 713-745-2702, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02390635
Organization ID
2014-0616
Secondary IDs
NCI-2015-00525
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Vikas Kundra, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
September 2019