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

February 26, 2024 updated by: M.D. Anderson Cancer Center

PET/MR, PET/CT and Whole Body MR in Newly Diagnosed Acute Myeloid Leukemia (AML)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Dawid Schellingerhout, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Gadolinium
Given IV
Other Names:
  • Gd
Procedure: Computed Tomography
Undergo 18F-FDG PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • tomography
  • computerized tomography
  • CT SCAN
Procedure: Diffusion Weighted Imaging
Undergo whole body PET/MRI
Other Names:
  • DWI
  • DW-MRI
  • Diffusion Weighted MRI
  • Diffusion-Weighted Magnetic Resonance Imaging
  • Diffusion-Weighted MR Imaging
  • Diffusion-Weighted MRI
  • DWI MRI
  • DWI-MRI
  • MR Diffusion-Weighted Imaging
Radiation: Fludeoxyglucose F-18
Undergo 18F-FDG PET/CT
Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose (18F)
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18
Procedure: Magnetic Resonance Imaging
Undergo whole body PET/MRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Undergo 18F-FDG PET/CT and whole body PET/MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Procedure: Three-Dimensional Spoiled Gradient MRI
Undergo whole body PET/MRI
Other Names:
  • 3-Dimensional Fast Spoiled Gradient
  • 3D Fast Spoiled Gradient Recalled MRI
  • 3D FSPGR
  • 3DFSPGR
  • FSPGR
  • FSPGR MRI
  • SPGR
  • SPGR MRI
  • Three-Dimensional Spoiled Gradient-Echo MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of extramedullary myeloid leukemia (EML)
Time Frame: 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.
At time of imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Dawid Schellingerhout, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2016

Primary Completion (Estimated)

September 15, 2024

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

March 11, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimated)

March 17, 2015

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0616 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2015-00525 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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