Recruiting
Phase 1

Imaging Techniques

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT02390635

Conditions

Acute Myeloid Leukemia

Acute Promyelocytic Leukemia With PML-RARA

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Diffusion Weighted Imaging

Fludeoxyglucose F-18

Gadolinium

Magnetic Resonance Imaging

Study Details

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.

Conditions

Acute Myeloid Leukemia

Acute Promyelocytic Leukemia With PML-RARA

Study ID

NCT02390635

Start date

Jul 15, 2020

Status verified date

Apr, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

77 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Computed Tomography

Undergo 18F-FDG PET/CT

Diffusion Weighted Imaging

Undergo whole body PET/MRI

Fludeoxyglucose F-18

Undergo 18F-FDG PET/CT

Gadolinium

Given IV

Magnetic Resonance Imaging

Undergo whole body PET/MRI

Positron Emission Tomography

Undergo 18F-FDG PET/CT and whole body PET/MRI

Three-Dimensional Spoiled Gradient MRI

Undergo whole body PET/MRI

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Dawid Schellingerhout, MD

(713) 794-5673dawid.schellingerhout@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Dawid Schellingerhout, MD

713-794-5673dawid.schellingerhout@mdanderson.org

Principal Investigator:

Dawid Schellingerhout, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-17.