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Trial Title:
PET Tracer Based FDG Signal for Predicting Prognosis in Acute Myeloid Leukemia
NCT ID:
NCT05919199
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
Acute Myeloid Leukemia
Bone marrow micro-environment
18F-fluorodeoxyglucose
cancer metabolism
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
No intervention
Arm group label:
AML patients, de novo or refractory/relapsed
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.
Criteria for eligibility:
Study pop:
AML patients in First Affiliated Hospital of Jinan University
Sampling method:
Probability Sample
Criteria:
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.)
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Jinan University
Address:
City:
Guangzhou
Zip:
510632
Country:
China
Start date:
January 3, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
First Affiliated Hospital of Jinan University
Agency class:
Other
Source:
First Affiliated Hospital of Jinan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05919199
