Clinical trial · Interventional
FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia
Early Assessment of Treatment Response in AML Using FLT PET/CT Imaging
NCT02392429CI-TRIAL-00112787active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This phase II trial studies fluorothymidine F 18 (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring response in patients with previously untreated acute myeloid leukemia. FLT is a radioactive substance that may "light up" where cancer is in the body. FLT is injected into the blood and builds up in cells that are dividing, including cancer cells. Diagnostic procedures, such as PET/CT, may help measure a patient's response to earlier treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Bone Marrow Aspiration | Procedure | — | UNRESOLVED |
| Bone Marrow Biopsy | Procedure | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Fluorothymidine F-18 | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Positron Emission Tomography |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (anthracycline, cytarabine, FLT PET/CT)
- description
- Patients receive anthracycline IV on days 1-3 and cytarabine IV on days 1-7 for up to 2 courses. Patients then undergo FLT PET/CT within 3 days before or after the nadir bone marrow biopsy (between days 10-17 after initiation of first induction cycle and prior to reinduction). Patients may undergo an optional FLT PET/CT prior to induction chemotherapy if it does not interfere with commencement of treatment. Patients also undergo bone marrow biopsy and aspiration and blood sample collection during screening and on the trial.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Bone Marrow Aspiration
- Procedure: Bone Marrow Biopsy
- Drug: Chemotherapy
- Procedure: Computed Tomography
- Drug: Cytarabine
- Other: Fluorothymidine F-18
- Other: Laboratory Biomarker Analysis
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- Negative Predictive Value of Post-treatment Fluorothymidine F 18 (FLT) Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging for Complete Remission (CR) in Comparison With Blast Counts From Bone Marrow Biopsy (BMBX)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Patients must have previously untreated AML and be candidates for intensive induction chemotherapy; patients are allowed to have had prior hydroxyurea * Patients must not have acute promyelocytic leukemia (APL) and must not have evidence of t(15;17)(q22;q21) * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status \[PS\] 0-2 if age \> 70 years) * Patients must have left ventricular ejection fraction (LVEF) \> 45% or within institutional normal limits * Patients must be able to lie still for a 1.5 hour PET scan * Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-fluorothymidine * Patient must NOT weigh more than the maximum weight limit for the PET/CT table for the scanner(s) to be used at each center * The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and received ECOG-ACRIN approval as outlined * Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
References
Publications (0)
Data not yet available
No reference posted for this study.