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

Brief Title

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

Official Title

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

Brief 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.
    

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 Phase

Phase 1

Study Type

Interventional

Primary Outcome

Incidence of extramedullary myeloid leukemia (EML)

Condition

Acute Myeloid Leukemia

Intervention

Computed Tomography

Study Arms / Comparison Groups

 Diagnostic (18F-FDG PET/CT, whole body PET/MRI)

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

55

Start Date

May 2, 2016

Completion Date

May 31, 2021

Primary Completion Date

May 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with newly diagnosed AML or acute promyelocytic leukemia (APL)

          -  Women of child bearing potential with negative pregnancy test documented

        Exclusion Criteria:

          -  Patients with contraindications to MR

          -  Patients with a creatinine clearance less than 60

          -  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

          -  Greater than 400 pounds in weight

          -  Patients with uncontrolled diabetes
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Vikas Kundra, 713-745-2702, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT02390635

Organization ID

2014-0616

Secondary IDs

NCI-2015-00525

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Vikas Kundra, Principal Investigator, M.D. Anderson Cancer Center

Verification Date

September 2019