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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
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 belowSelect...
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:Select...
I am under 18 years old.
Select...
My kidney function is reduced with a creatinine clearance below 60.
Select...
I have received more than minimal treatment for leukemia.
Select...
My AML or APL cancer has returned after treatment.
Select...
My leukemia has spread outside the bone marrow.
Select...
I weigh more than 400 pounds.
Select...
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
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)
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
~590
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
13,842 Previous Clinical Trials
41,002,945 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,646 Total Patients Enrolled
Dawid SchellingerhoutPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I have been recently diagnosed with AML or APL.I am a woman who can have children and have a negative pregnancy test.My kidney function is reduced with a creatinine clearance below 60.I have received more than minimal treatment for leukemia.My AML or APL cancer has returned after treatment.My leukemia has spread outside the bone marrow.I weigh more than 400 pounds.My diabetes is not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (18F-FDG PET/CT, whole body PET/MRI)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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