PET Tracer Based FDG Signal for Predicting Prognosis in Acute Myeloid Leukemia (FDG-PETAML)

Jinan University

Status: Invitation-only

Conditions: Acute Myeloid Leukemia

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05919199

MR-44-23-012821

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

60 participants in 1 patient group

AML patients, de novo or refractory/relapsed

Description:

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.

Treatment:

Other: No intervention