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

NCT05919199 | Unknown

• 1 other identifier: MR-44-23-012821
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite complete remission rate (CRc)

  Partial response (PR) + complete response (CR) rate

  At the end of Cycle 2 (each cycle is about 28 days)

Secondary Outcomes (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

Study Arms (1)

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

Interventions

No intervention OTHER

No intervention

AML patients, de novo or refractory/relapsed

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

AML patients in First Affiliated Hospital of Jinan University

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• Uncontrolled systemic diseases (such as diabetes, non controlled heart failure, etc.)

Sponsors & Collaborators

• First Affiliated Hospital of Jinan University: lead

Study Sites (1)

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510632, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hui Zeng

  First Affiliated Hopital of Jinan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hematology Department of the First Affiliated Hospital of Jinan University

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 26, 2023
• Study Start: January 3, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)