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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02390635
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo 18F-FDG PET/CT
  • Diffusion Weighted Imaging — PROCEDURE
    Undergo whole body PET/MRI
  • Fludeoxyglucose F-18 — RADIATION
    Undergo 18F-FDG PET/CT
  • Gadolinium — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo whole body PET/MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo 18F-FDG PET/CT and whole body PET/MRI
  • Three-Dimensional Spoiled Gradient MRI — PROCEDURE
    Undergo whole body PET/MRI

Study Details

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.

Key Dates

Start date
Jul 15, 2020
Status verified
Apr 2026
Primary completion
Sep 15, 2027
Completion
Sep 15, 2027

Study Design

Enrollment
77 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.

Primary Outcome Measure

Incidence of extramedullary myeloid leukemia (EML) [ Time Frame: At time of imaging ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Dawid Schellingerhout, MD
713-794-5673
Dawid Schellingerhout, MD (PRINCIPAL_INVESTIGATOR)

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