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NCT02390635 · ClinicalTrials.gov registry record · Phase 1
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 of Acute Myeloid Leukemia and Acute Promyelocytic Leukemia With PML-RARA, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT02390635: Active Phase 1 study of Acute Myeloid Leukemia and Acute Promyelocytic Leukemia With PML-RARA, sponsored by M.D. Anderson Cancer Center.
NCT02390635 is a Phase 1 study of Acute Myeloid Leukemia and Acute Promyelocytic Leukemia With PML-RARA that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 77 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (34% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02390635, a Phase 1 study of Acute Myeloid Leukemia and Acute Promyelocytic Leukemia With PML-RARA, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Gadolinium
- RADIATION Fludeoxyglucose F-18
- PROCEDURE Diffusion Weighted Imaging
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2020-07-15 |
| Est. Completion | 2027-09-15 |
| Phase | Phase 1 |
What the registry record for NCT02390635 still lists
NCT02390635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (34% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT02390635 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02390635 about?
NCT02390635 is a clinical study titled "PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia". 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. Extr...
What is the current status of trial NCT02390635?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2020-07-15. Estimated completion is 2027-09-15.
What conditions does trial NCT02390635 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Promyelocytic Leukemia With PML-RARA.
What interventions are being tested in trial NCT02390635?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Gadolinium (DRUG), Fludeoxyglucose F-18 (RADIATION), Diffusion Weighted Imaging (PROCEDURE).
Who is sponsoring clinical trial NCT02390635?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02390635 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02390635's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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