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

This study is looking at how well different imaging tests can find extramedullary myeloid leukemia (EML) in people who have just been diagnosed with acute myeloid leukemia (AML). EML is a type of cancer that can be found outside of the bone marrow. The imaging tests being studied are PET/MRI, 18F-FDG PET/CT, and whole body MRI. You would receive gadolinium (a contrast agent) intravenously (into a vein) and undergo a whole body PET/MRI, followed by an 18F-FDG PET/CT scan. Researchers want to see how often EML is found with these tests. This study aims to enroll 77 participants aged 18 or older with newly diagnosed AML. The current status of the study is unclear.

Study design
This is an interventional study with a planned enrollment of 77 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive gadolinium intravenously and undergo a whole body PET/MRI, then an 18F-FDG PET/CT scan before starting treatment for acute myeloid leukemia.
Compensation
Not stated in the trial record.
Follow-up
After completing the study procedures, patients are followed up periodically.

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NCT02390635

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

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
M.D. Anderson Cancer Center
~77 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:Computed TomographyDiffusion Weighted ImagingFludeoxyglucose F-18GadoliniumMagnetic Resonance ImagingPositron Emission Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of extramedullary myeloid leukemia (EML)
Measured over At time of imaging

Conditions

Acute Myeloid Leukemia
Acute Promyelocytic Leukemia With PML-RARA

Explore related trials

Acute Myeloid LeukemiaAcute Promyelocytic Leukemia

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Dawid Schellingerhout · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Dawid Schellingerhout, MD
[email protected]
(713) 794-5673
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.