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

January 31, 2016 updated by: Woo Hee Choi, MD, The Catholic University of Korea
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyenggi-do
      • Suwon, Gyenggi-do, Korea, Republic of, 442-060
        • St. Vincent's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no standard therapy
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FLT PET/CT
Patients who had FLT PET/CT
Other: FLT PET/CT
All PET/CT scans were performed using a hybrid PET/CT scanner (Gemini TF 64 with Astonish TF, Philips). F-18 FLT (2.96 MBq/kg) in 2-5 mL of normal saline was injected intravenously. One hour after FLT injection, CT began at the vertex and progressed to the upper thigh (120 kVp, 100 mA and 4 mm slice thickness). PET emission data were acquired immediately for 1 min at each bed position followed. The CT data were used for attenuation correction. Images were reconstructed using a standard ordered-subset expectation maximization algorithm with 3 iterations and 33 subsets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value of FLT PET/CT in early response assessment of induction chemotherapy in acute myeloid leukemia
Time Frame: 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
4-6 wks after completion of induction chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Woo Hee Choi, MD, St. Vincent's Hospital, The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (ESTIMATE)

April 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 31, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VC13MISI0184

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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