PET Tracer Based FDG Signal for Predicting Prognosis in A... | NCT05919199

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

NCT05919199

Sponsor

First Affiliated Hospital of Jinan University

Status

Unknown status

Last Update Posted

Jun 26, 2023Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Acute Myeloid Leukemia

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2023Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Jun 14, 2023

First Submission Date that Met QC Criteria

Jun 22, 2023

First Posted Date

Jun 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2023

Last Update Posted Date

Jun 26, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hui Zeng, Director of Hematology Department of the First Affiliated Hospital of Jinan University, First Affiliated Hospital of Jinan UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Jinan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	AML patients, de novo or refractory/relapsed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Progress-free survival (PFS )	Relapse or death of any cause	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

AML patients in First Affiliated Hospital of Jinan University

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hui Zeng	First Affiliated Hopital of Jinan University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Jinan University		Guangzhou	Guangdong	510632	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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