Acute Myeloid LeukemiaNCT02103530
Early Response Assessment of Induction Chemotherapy in Acute Myeloid Leukemia Patients Using F-18 FLT PET/CT
A study testing FLT PET/CT in people with Acute Myeloid Leukemia, run by The Catholic University of Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- FLT PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute myeloid leukemia
- must receive induction chemotherapy
- 19 years old and over
Who cannot join
- no standard therapy
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- FLT PET/CT
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLT PET/CTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FLT PET/CT | Experimental | Patients who had FLT PET/CT Receives: Other: FLT PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4-6 wks after completion of induction chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Hee Choi, MD, The Catholic University of Korea
- Investigators
- Woo Hee Choi, MD, Principal investigator, St. Vincent's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103530
- Sponsor's protocol ID
- VC13MISI0184
- Status last verified
- Jan 2016
- First submitted
- 3 Feb 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Response Assessment of Induction Chemotherapy in Acute Myeloid Leukemia Patients Using F-18 FLT PET/CT
- ClinicalTrials.gov ID
- NCT02103530
- Acronym / sponsor ID
- VC13MISI0184
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLT PET/CT | Experimental | Other: FLT PET/CTPatients who had FLT PET/CT |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute myeloid leukemia
- must receive induction chemotherapy
- 19 years old and over
Key exclusion criteria (2 listed)
- no standard therapy
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLT PET/CTAll 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. | Other | FLT PET/CT |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woo Hee Choi, MD principal investigator
St. Vincent's Hospital, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLT PET/CT in people with Acute Myeloid Leukemia, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.