PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia
PET/MR, PET/CT and Whole Body MR in Newly Diagnosed Acute Myeloid Leukemia (AML)
Sponsor: M.D. Anderson Cancer Center
A observational or N/A phase clinical study on Acute Myeloid Leukemia and Acute Promyelocytic Leukemia With PML-RARA, this trial is actively recruiting participants. The trial is conducted by M.D. Anderson Cancer Center and has accumulated 22 data snapshots since 2020. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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.
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.
Status Flow
Change History
22 versions recorded-
Apr 18, 2026 — Present [daily]
Recruiting
Status: Active Not Recruiting → Recruiting · Phase: PHASE1 → None
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Dec 2025 — Apr 2026 [monthly]
Active Not Recruiting PHASE1
Status: Recruiting → Active Not Recruiting
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Jun 2025 — Dec 2025 [monthly]
Recruiting PHASE1
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Dec 2024 — Jun 2025 [monthly]
Recruiting PHASE1
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Sep 2024 — Dec 2024 [monthly]
Recruiting PHASE1
▶ Show 17 earlier versions
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Aug 2024 — Sep 2024 [monthly]
Recruiting PHASE1
Status: Active Not Recruiting → Recruiting
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Jul 2024 — Aug 2024 [monthly]
Active Not Recruiting PHASE1
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Jun 2024 — Jul 2024 [monthly]
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Mar 2024 — Jun 2024 [monthly]
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Dec 2023 — Mar 2024 [monthly]
Recruiting PHASE1
Status: Active Not Recruiting → Recruiting
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Apr 2023 — Dec 2023 [monthly]
Active Not Recruiting PHASE1
Status: Unknown Status → Active Not Recruiting
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Oct 2021 — Apr 2023 [monthly]
Unknown Status PHASE1
Status: Recruiting → Unknown Status
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Jan 2021 — Oct 2021 [monthly]
Recruiting PHASE1
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Oct 2019 — Jan 2021 [monthly]
Recruiting PHASE1
Status: Active Not Recruiting → Recruiting
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Aug 2019 — Oct 2019 [monthly]
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Status: Recruiting → Active Not Recruiting
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Jul 2019 — Aug 2019 [monthly]
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Oct 2018 — Jun 2019 [monthly]
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Nov 2017 — Jun 2018 [monthly]
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Feb 2017 — Nov 2017 [monthly]
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Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE1
First recorded
Eligibility 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.
Contact Information
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .