Early Response Assessment of Induction Chemotherapy in Acute Myeloid Leukemia Patients Using F-18 FLT PET/CT

Not Applicable

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Other: FLT PET/CT

• Registration Number: NCT02103530
• Lead Sponsor: The Catholic University of Korea

Brief Summary

The purpose of this study is to investigate whether F-18 FLT PET/CT is useful in early response assessment of induction chemotherapy in acute myeloid leukemia patients.

Detailed Description

Assessment of treatment response in AML is very important to determine the next treatment. Standard treatment of AML begins with induction chemotherapy. NCCN guideline recommend to assess the treatment response via bone marrow examination approximately 7-10 days after completion of induction chemotherapy. However, the possibility of sampling error and risks of infection and bleeding are the limitation of bone marrow biopsy.

F-18 fluorodeoxythymidine (FLT) is a radiopharmaceutical for PET, reflecting the proliferation of the cell. F-18 FLT is trapped after phosphorylation by thymidine kinase1, whose expression is increased in replicating cells. There have been several studies that reported F-18 FLT PET could measure health and proliferation of the bone marrow.

The aim of this study is to evaluate if F-18 FLT PET/CT is suitable for early response assessment of induction chemotherapy in acute myeloid leukemia patients.

Study Timeline

• Study First Submitted: 2014-02-03
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-31
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• acute myeloid leukemia
• must receive induction chemotherapy
• 19 years old and over

Exclusion Criteria

• no standard therapy
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLT PET/CT	FLT PET/CT	Patients who had FLT PET/CT

Primary Outcome Measures

Name	Time	Method
Value of FLT PET/CT in early response assessment of induction chemotherapy in acute myeloid leukemia	4-6 wks after completion of induction chemotherapy	Correlation between the FLT PET/CT findings on day 8-12 after start of treatment with the result of bone marrow biopsy which is done 4-6 wks after completion of induction chemotherapy

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇰🇷 Suwon, Gyenggi-do, Korea, Republic of