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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

16mo left

Started Jul 2020

Longer than P75 for phase_1

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7.2 years study duration

Study Progress81%

Jul 2020Sep 2027

First Submitted

Initial submission to the registry

March 11, 2015

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed

5.3 years until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed

7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

7.2 years

First QC Date

March 11, 2015

Last Update Submit

April 14, 2026

Conditions

Acute Myeloid Leukemia Acute Promyelocytic Leukemia With PML-RARA

Outcome Measures

Primary Outcomes (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.
At time of imaging

Study Arms (1)

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

EXPERIMENTAL

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.

Procedure: Computed TomographyProcedure: Diffusion Weighted ImagingRadiation: Fludeoxyglucose F-18Drug: GadoliniumProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyProcedure: Three-Dimensional Spoiled Gradient MRI

Interventions

Computed TomographyPROCEDURE

Undergo 18F-FDG PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography