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

NCT ID: NCT05919199

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-03

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Jinan University

OTHER

Sponsor Role lead

Responsible Party

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Hui Zeng

Director of Hematology Department of the First Affiliated Hospital of Jinan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hui Zeng

Role: STUDY_CHAIR

First Affiliated Hopital of Jinan University

Locations

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First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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MR-44-23-012821

Identifier Type: -

Identifier Source: org_study_id

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