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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103530
• Other study ID #: VC13MISI0184
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: January 31, 2016
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• acute myeloid leukemia

• must receive induction chemotherapy

• 19 years old and over

Exclusion Criteria:

• no standard therapy

• pregnancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital	Suwon	Gyenggi-do

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4-6 wks after completion of induction chemotherapy	No