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Imaging Techniques for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Dawid Schellingerhout

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Younger than 18 years

Patients with a creatinine clearance less than 60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of imaging

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is looking at using PET/MRI, 18F-FDG PET/CT, and whole body MRI to detect extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia.

Who is the study for?

This trial is for patients with newly diagnosed acute myeloid leukemia (AML) or acute promyelocytic leukemia (APL). Women who can have children must show a negative pregnancy test to participate.

What is being tested?

The study tests how well PET/MRI, 18F-FDG PET/CT, and whole body MRI detect extramedullary myeloid leukemia in new AML patients. These imaging techniques may improve diagnosis of cancer outside the bone marrow.

What are the potential side effects?

Since this trial focuses on diagnostic procedures rather than treatments, side effects are minimal but may include discomfort during scans and potential allergic reactions to contrast agents like Gadolinium.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been recently diagnosed with AML or APL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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My kidney function is reduced with a creatinine clearance below 60.

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I have received more than minimal treatment for leukemia.

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My AML or APL cancer has returned after treatment.

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My leukemia has spread outside the bone marrow.

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I weigh more than 400 pounds.

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My diabetes is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of imaging

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of imaging

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of imaging for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of extramedullary myeloid leukemia (EML)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (18F-FDG PET/CT, whole body PET/MRI)Experimental Treatment7 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludeoxyglucose (18F)

FDA approved

Computed Tomography

2017

Completed Phase 2

~2790

Diffusion Weighted Imaging

2006