AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 1NCT02390635

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

A Phase 1 study testing Computed Tomography, Diffusion Weighted Imaging and Fludeoxyglucose F-18 in people with Acute Myeloid Leukemia and Acute Promyelocytic Leukemia With PML-RARA, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Computed Tomography, Diffusion Weighted Imaging and Fludeoxyglucose F-18
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteUnited States
Study dates
15 Jul 2020to 15 Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dawid Schellingerhout, MD contact

(713) 794-5673

dawid.schellingerhout@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Dawid Schellingerhout, MD, 713-794-5673, dawid.schellingerhout@mdanderson.org

    Dawid Schellingerhout, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Computed Tomography, Diffusion Weighted Imaging, Fludeoxyglucose F-18, Gadolinium, Magnetic Resonance Imaging
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia, Promyelocytic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography

    Undergo 18F-FDG PET/CT

  • Diffusion Weighted ImagingProcedure or surgery

    Also called Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI

    Undergo whole body PET/MRI

  • Fludeoxyglucose F-18Radiation

    Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18

    Undergo 18F-FDG PET/CT

  • GadoliniumDrug

    Also called Gd

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI

    Undergo whole body PET/MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

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

  • Three-Dimensional Spoiled Gradient MRIProcedure or surgery

    Also called 3-Dimensional Fast Spoiled Gradient, 3D Fast Spoiled Gradient Recalled MRI, 3D FSPGR, 3DFSPGR

    Undergo whole body PET/MRI

Study groups in NCT02390635
Study groupRoleWhat they receive
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)ExperimentalPatients 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.
Receives: Procedure: Computed Tomography; Procedure: Diffusion Weighted Imaging; Radiation: Fludeoxyglucose F-18; Drug: Gadolinium; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Three-Dimensional Spoiled Gradient MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of extramedullary myeloid leukemia (EML)

    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.

    Measured: At time of imaging

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2015 (estimated)
  2. Study start15 Jul 2020
  3. Primary completion15 Sep 2027 (estimated)
  4. Study completion15 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
77 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02390635
Sponsor's protocol ID
2014-0616
Other IDs
NCI-2015-00525, 2014-0616
Status last verified
Oct 2026
First submitted
11 Mar 2015
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Computed Tomography, Diffusion Weighted Imaging and Fludeoxyglucose F-18 in people with Acute Myeloid Leukemia and Acute Promyelocytic Leukemia With PML-RARA, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dawid Schellingerhout, MD ((713) 794-5673, dawid.schellingerhout@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of extramedullary myeloid leukemia (EML) (time frame: At time of imaging). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02390635.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in