PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT ID: NCT02390635
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
77 participants
INTERVENTIONAL
2020-07-15
2027-09-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (18F-FDG PET/CT, whole body PET/MRI)
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.
Computed Tomography
Undergo 18F-FDG PET/CT
Diffusion Weighted Imaging
Undergo whole body PET/MRI
Fludeoxyglucose F-18
Undergo 18F-FDG PET/CT
Gadolinium
Given IV
Magnetic Resonance Imaging
Undergo whole body PET/MRI
Positron Emission Tomography
Undergo 18F-FDG PET/CT and whole body PET/MRI
Three-Dimensional Spoiled Gradient MRI
Undergo whole body PET/MRI
Interventions
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Computed Tomography
Undergo 18F-FDG PET/CT
Diffusion Weighted Imaging
Undergo whole body PET/MRI
Fludeoxyglucose F-18
Undergo 18F-FDG PET/CT
Gadolinium
Given IV
Magnetic Resonance Imaging
Undergo whole body PET/MRI
Positron Emission Tomography
Undergo 18F-FDG PET/CT and whole body PET/MRI
Three-Dimensional Spoiled Gradient MRI
Undergo whole body PET/MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Dawid Schellingerhout
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2015-00525
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-0616
Identifier Type: OTHER
Identifier Source: secondary_id
2014-0616
Identifier Type: -
Identifier Source: org_study_id
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