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

Sponsor
First Affiliated Hospital of Jinan University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05919199
Collaborator
(none)
60
1
22.9
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The Efficiency of 18F-FDG PET Probe Signal in Bone Marrow for Predicting Acute Myeloid Leukemia Patients' Response to Induction Therapy
Actual Study Start Date :
Jan 3, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
AML patients, de novo or refractory/relapsed

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
No intervention

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital of Jinan University Guangzhou Guangdong China 510632

Sponsors and Collaborators

  • First Affiliated Hospital of Jinan University

Investigators

  • Study Chair: Hui Zeng, First Affiliated Hopital of Jinan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hui Zeng, Director of Hematology Department of the First Affiliated Hospital of Jinan University, First Affiliated Hospital of Jinan University
ClinicalTrials.gov Identifier:
NCT05919199
Other Study ID Numbers:
  • MR-44-23-012821
First Posted:
Jun 26, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hui Zeng, Director of Hematology Department of the First Affiliated Hospital of Jinan University, First Affiliated Hospital of Jinan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2023