Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05919199
Acronym
FDG-PETAML
Enrollment
60
Registered
2023-06-26
Start date
2023-01-03
Completion date
2024-12-31
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia, Bone marrow micro-environment, 18F-fluorodeoxyglucose, cancer metabolism

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

First Affiliated Hospital of Jinan University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 monthsRelapse or death of any cause

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026