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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 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
~2740
Diffusion Weighted Imaging
2006
Completed Phase 2
~150
Fludeoxyglucose F-18
2018
Completed Phase 4
~610
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Positron Emission Tomography
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,983 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,591 Total Patients Enrolled
Dawid SchellingerhoutPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Diagnostic (18F-FDG PET/CT, whole body PET/MRI) Clinical Trial Eligibility Overview. Trial Name: NCT02390635 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Diagnostic (18F-FDG PET/CT, whole body PET/MRI)
Acute Myeloid Leukemia Clinical Trial 2023: Diagnostic (18F-FDG PET/CT, whole body PET/MRI) Highlights & Side Effects. Trial Name: NCT02390635 — Phase 1
Diagnostic (18F-FDG PET/CT, whole body PET/MRI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02390635 — Phase 1
~8 spots leftby Sep 2025