FLT PET/CT 测量既往未治疗的急性髓性白血病患者的反应
使用 FLT PET/CT 成像对 AML 治疗反应的早期评估
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.
研究概览
地位
条件
详细说明
PRIMARY OBJECTIVES:
I. To evaluate the negative predictive value (NPV) of post-treatment FLT PET/CT imaging for complete remission (CR) in patients receiving induction chemotherapy for acute myeloid leukemia (AML).
SECONDARY OBJECTIVES:
I. To evaluate the positive predictive value (PPV) of post-treatment FLT PET/CT imaging for complete remission.
II. To estimate the sensitivity and specificity of post-treatment FLT PET/CT imaging for detecting complete remission.
III. To correlate FLT PET/CT imaging with biologic correlates (minimal residual disease [MRD] assessment) IV. To correlate FLT PET/CT imaging with relapse-free survival and overall survival.
EXPLORATORY OBJECTIVES:
III. To evaluate pre-treatment FLT PET/CT imaging as a predictor of complete remission.
IV. To evaluate the change between pre-treatment and post-treatment FLT PET/CT imaging as a predictor of complete remission.
OUTLINE:
Patients receive anthracycline intravenously (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.
After completion of study, patients are followed up at day 28-35, and then up to 1 year beyond the end of study accrual period.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic in Rochester
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Missouri
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St Louis、Missouri、美国、63110
- Washington University School of Medicine
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New York
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New York、New York、美国、10029
- Mount Sinai Hospital
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- UNC Lineberger Comprehensive Cancer Center
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Oklahoma
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Oklahoma City、Oklahoma、美国、73104
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19111
- Fox Chase Cancer Center
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania/Abramson Cancer Center
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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt University/Ingram Cancer Center
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Texas
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Dallas、Texas、美国、75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Utah
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Salt Lake City、Utah、美国、84112
- Huntsman Cancer Institute/University of Utah
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Wisconsin
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Madison、Wisconsin、美国、53792
- University of Wisconsin Carbone Cancer Center - University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Diagnostic (anthracycline, cytarabine, FLT PET/CT)
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. |
Correlative studies Given IV
其他名称：
Undergo blood sample collection
其他名称：
Undergo bone marrow biopsy and aspiration Undergo bone marrow biopsy and aspiration
其他名称：
Given anthracycline IV
其他名称：
Undergo FLT PET/CT
其他名称：
Undergo FLT PET/CT
其他名称：
Undergo FLT PET/CT
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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)
大体时间：Up to day 35
|
Three imaging parameters (standardized uptake value [SUV]mean, SUVmax, heterogeneity of FLT uptake [SUVhetero]) will be measured from an FLT PET/CT scan and SUVmax will be the primary endpoint. Higher values of SUVmax assume to indicate a non-response the therapy and a cut point of 7 (SUVmax >7) will be used as the threshold indicating a negative scan. The binomial proportion of negative predictive value (NPV) and the corresponding exact confidence intervals will be calculated. In addition, the calculated NPV will be tested against the null hypothesis to see if it's significantly larger than 0.64 (NPV of day-14 BMBX in CR prediction). CR:Complete remission CRi: Complete remission with incomplete platelet recovery LFS: Leukemia-free state Non-responders defined as Not (CR,CRi,or LFS) Negative predictive value (NPV) of the post-treatment FLT PET/CT scan is Probability ((not CR,CRi,or LFS) │ SUVmax >7 ) |
Up to day 35
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Positive Predictive Value (PPV) of Post-treatment FLT PET/CT Imaging for Complete Remission
大体时间：Up to day 35
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The binomial proportion of PPV and the corresponding exact confidence intervals will be calculated. In addition, the calculated PPV will be tested to see if it's significantly larger than 0.79 (PPV of day-14 BMBX in CR prediction). |
Up to day 35
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Sensitivity of Post-treatment FLT PET/CT for Detecting Complete Remission (a Clinical Response of CR, CRi, or LFS )
大体时间：Up to day 35
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The binomial proportions and the corresponding exact confidence intervals will be calculated for sensitivity estimation where FLT Test : Negative: SUV >7; Positive: SUV<=7 Clinical Response: Negative: not (CR, CRi, or LFS); Positive (Responders): CR, CRi, or LFS |
Up to day 35
|
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Specificity of Post-treatment FLT PET/CT for Detecting Complete Remission
大体时间：Up to day 35
|
The binomial proportions and the corresponding exact confidence intervals will be calculated for specificity estimation. Test response: Negative: SUV >7; Positive: SUV<=7 Clinical Response = Complete remissions: Negative (Non-Responders): not (CR, CRi, or LFS); Positive (Responders): CR, CRi, or LFS |
Up to day 35
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FLT PET/CT Imaging Parameters With Biologic Correlates (Minimal Residual Disease Assessment)
大体时间：Up to day 35
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FLT PET/CT imaging features will be compared with biologic correlates (minimal residual disease [MRD] assessment). |
Up to day 35
|
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FLT PET/CT Imaging to Predict Relapse-free Survival
大体时间：Up to day 35 and up to 4 years for RFS
|
compare the Recurrence-Free Survival (RFS) between positive and negative post-treatment FLT PET/CT scans, where an SUVmax less than or equal to 7 (i.e., low FLT uptake) was considered a positive result, and an SUVmax greater than 7 (i.e., high FLT uptake) was a negative result. Participants were followed for survival outcomes until study closure when the last participant has been followed for 1 year after study enrollment. The relapse endpoint included both reappearance of blasts in the blood; and presence of more than 5% blasts not attributable to another cause Time-to-relapse was measured from the date of the remission bone marrow biopsy to the date of first recurrence or death, whichever came first. RFS was only evaluable for participants with a clinical response of CR, CRi, or LFS at the remission bone marrow biopsy. |
Up to day 35 and up to 4 years for RFS
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|
FLT PET/CT Imaging to Predict Overall Survival
大体时间：Up to day 35 and up to 4 years for RFS
|
compare the Overall Survival (OS) between positive and negative post-treatment FLT PET/CT scans, where an SUVmax<= 7 (i.e., low FLT uptake) was considered a positive result, and an SUVmax > 7 (i.e., high FLT uptake) was a negative result. Participants were followed for survival outcomes until study closure when the last participant has been followed for 1 year after study enrollment. |
Up to day 35 and up to 4 years for RFS
|
合作者和调查者
调查人员
- 首席研究员：Robert Jeraj、ECOG-ACRIN Cancer Research Group
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NCI-2015-00328
- U10CA180820 (美国 NIH 拨款/合同)
- NCI-2015-00328 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- EAI141 (其他标识符：CTEP)
- U10CA180827 (美国 NIH 拨款/合同)
- EAI141
- EAI141 (其他标识符：ECOG-ACRIN Cancer Research Group)
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