Early Response Assessment of Induction Chemotherapy in Acute Myeloid Leukemia Patients Using F-18 FLT PET/CT

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether F-18 FLT PET/CT is useful in early response assessment of induction chemotherapy in acute myeloid leukemia patients.

Detailed Description
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Assessment of treatment response in AML is very important to determine the next treatment. Standard treatment of AML begins with induction chemotherapy. NCCN guideline recommend to assess the treatment response via bone marrow examination approximately 7-10 days after completion of induction chemotherapy. However, the possibility of sampling error and risks of infection and bleeding are the limitation of bone marrow biopsy. F-18 fluorodeoxythymidine (FLT) is a radiopharmaceutical for PET, reflecting the proliferation of the cell. F-18 FLT is trapped after phosphorylation by thymidine kinase1, whose expression is increased in replicating cells. There have been several studies that reported F-18 FLT PET could measure health and proliferation of the bone marrow. The aim of this study is to evaluate if F-18 FLT PET/CT is suitable for early response assessment of induction chemotherapy in acute myeloid leukemia patients.

Official Title
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Early Response Assessment of Induction Chemotherapy in Acute Myeloid Leukemia Patients Using F-18 FLT PET/CT

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Other: FLT PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute myeloid leukemia must receive induction chemotherapy 19 years old and over Exclusion Criteria: no standard therapy pregnancy

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLT PET/CT<br>Patients who had FLT PET/CT | Other: FLT PET/CT<br>* All PET/CT scans were performed using a hybrid PET/CT scanner (Gemini TF 64 with Astonish TF, Philips). F-18 FLT (2.96 MBq/kg) in 2-5 mL of normal saline was injected intravenously. One hour after FLT injection, CT began at the vertex and progressed to the upper thigh (120 kVp, 100 mA and 4 mm slice thickness). PET emission data were acquired immediately for 1 min at each bed position followed. The CT data were used for attenuation correction. Images were reconstructed using a standard ordered-subset expectation maximization algorithm with 3 iterations and 33 subsets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of FLT PET/CT in early response assessment of induction chemotherapy in acute myeloid leukemia | Correlation between the FLT PET/CT findings on day 8-12 after start of treatment with the result of bone marrow biopsy which is done 4-6 wks after completion of induction chemotherapy | 4-6 wks after completion of induction chemotherapy |