PET Tracer Based FDG Signal for Predicting Prognosis in Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Other: No intervention
- Registration Number
- NCT05919199
- Lead Sponsor
- First Affiliated Hospital of Jinan University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 60
- 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
- Pregnant
- Uncontrolled systemic diseases (such as diabetes, non controlled heart failure, etc.)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AML patients, de novo or refractory/relapsed No intervention 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.
- Primary Outcome Measures
Name Time Method Composite complete remission rate (CRc) At the end of Cycle 2 (each cycle is about 28 days) Partial response (PR) + complete response (CR) rate
- Secondary Outcome Measures
Name Time Method Progress-free survival (PFS ) 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 Relapse or death of any cause
Trial Locations
- Locations (1)
First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China