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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FLT PET/CT
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Myeloid Leukemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • no standard therapy
  • pregnancy

Sites / Locations

  • St. Vincent's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLT PET/CT

Arm Description

Patients who had FLT PET/CT

Outcomes

Primary Outcome Measures

Value of FLT PET/CT in early response assessment of induction chemotherapy in acute myeloid leukemia
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

Secondary Outcome Measures

Full Information

First Posted
February 3, 2014
Last Updated
January 31, 2016
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02103530
Brief Title
Early Response Assessment of Induction Chemotherapy in Acute Myeloid Leukemia Patients Using F-18 FLT PET/CT
Official Title
Early Response Assessment of Induction Chemotherapy in Acute Myeloid Leukemia Patients Using F-18 FLT PET/CT
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FLT PET/CT
Arm Type
Experimental
Arm Description
Patients who had FLT PET/CT
Intervention Type
Other
Intervention Name(s)
FLT PET/CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Value of FLT PET/CT in early response assessment of induction chemotherapy in acute myeloid leukemia
Description
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
Time Frame
4-6 wks after completion of induction chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute myeloid leukemia must receive induction chemotherapy 19 years old and over Exclusion Criteria: no standard therapy pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Hee Choi, MD
Organizational Affiliation
St. Vincent's Hospital, The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Hospital
City
Suwon
State/Province
Gyenggi-do
ZIP/Postal Code
442-060
Country
Korea, Republic of

12. IPD Sharing Statement

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

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