PET Tracer Based FDG Signal for Predicting Prognosis in Acute Myeloid Leukemia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the predictive value of 18F-FDG PET probe signal in de novo diagnosed or refractory/relapsed patients with acute myeloid leukemia. It is hypothesized that the intensity of 18F-FDG signal, an indicator of glucose uptake capacity, in various cell subsets of bone marrow will improve the predictive effect of clinical standard prognostic work-up.

Detailed Description
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Rationale: FDG is incorporated by leukemia cells and other cell subsets in bone marrow micro-environment of various degree. The heterogeneous FDG uptake is a promising marker for predicting response to treatment. The investigators will collect bone marrow under standard clinical work-up after 18F-FDG PET/CT scan and correlate the FDG signal intensity with clinical and genomics features of the patients to explore its prognostic significance. Objective: The primary objective of this research project is to investigate the intensity of FDG PET probe based glucose uptake signal in predicting induction treatment response of AML. As secondary objectives, this analysis will be applied to calculate the overall predictive specificity and sensitivity of FDG probe avidity in predicting PFS and OS.

Official Title
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The Efficiency of 18F-FDG PET Probe Signal in Bone Marrow for Predicting Acute Myeloid Leukemia Patients' Response to Induction Therapy

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Acute myeloid leukemia, non APL Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Patients voluntarily participated in this study and signed the informed consent Exclusion Criteria: Pregnant Uncontrolled systemic diseases (such as diabetes, non controlled heart failure, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AML patients, de novo or refractory/relapsed<br>The investigators will collect bone marrow cells under standard clinical work-up after 18F-FDG PET/CT scan and correlate the FDG signal with extramedullary infiltration, histopathological, genomics features of the patients to explore the prognostic value of FDG signal in AML. | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite complete remission rate (CRc) | Partial response (PR) + complete response (CR) rate | At the end of Cycle 2 (each cycle is about 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress-free survival (PFS ) | Relapse or death of any cause | From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia, Bone marrow micro-environment, 18F-fluorodeoxyglucose, cancer metabolism