Hyperpolarized 13C Pyruvate MRI for Treatment Response Assessment in Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Cohort A: Signal-to-noise Ratio of the Target Lesion 13C Pyruvate Metabolism Measures Will be Determined for Each Patient
研究概览
简要总结
This phase II trial investigates whether magnetic resonance imaging (MRI) using hyperpolarized carbon-13 (13C) pyruvate can be useful for evaluating early treatment response in patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or spread to other places in the body (metastatic). Hyperpolarized 13C pyruvate is different from standard clinical MRI contrast (e.g. gadolinium) in that it provides information on how a tumor processes nutrients. MRI is used to see tumor uptake and breakdown of hyperpolarized carbon-13 pyruvate molecules, which can tell how the tumor processes nutrients. Hyperpolarized 13C pyruvate MRI may help in understanding how the tumor responds to the treatments patients may be receiving.
详细描述
PRIMARY OBJECTIVES:
I. To determine the signal-to-noise ratio of 13C pyruvate metabolism (peak 13C lactate/pyruvate ratio, 13C lactate/pyruvate area-under-the-curve (AUC) ratio, and apparent rate constant for pyruvate-to-lactate conversion, kPL) in the target tumor (primary tumor and/or abdominal metastases) in Cohort A.
II. To determine the percent changes in the target tumor (primary tumor and/or abdominal metastases) 13C pyruvate metabolism (peak 13C lactate/pyruvate ratio, 13C lactate/pyruvate AUC ratio, and kPL) between pre-treatment scan and scan obtained at 4-week (+/-2 weeks) following treatment initiation in Cohort B.
SECONDARY OBJECTIVES:
I. To determine the repeatability of 13C pyruvate metabolism measures in the target tumor (primary tumor and/or abdominal metastasis) in patients with same-day repeated dose in Cohort A and B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced or metastatic pancreatic ductal adenocarcinoma, with at least one target lesion in the abdomen measuring >= 1 cm
- •The subject is able and willing to comply with study procedures and provide signed and dated informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent
- •Patients unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips
- •Poorly controlled hypertension, defined as either systolic > 170 or diastolic >
- •The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination
- •Congestive heart failure >= class III
- •Myocardial infarction within the past year
- •History of QT prolongation on electrocardiogram (EKG), defined as pretreatment QTs > 440 msec in males or > 460 msec in females
- •Pregnant and lactating females
研究组 & 干预措施
Cohort A: Single Dose/Image
Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than one minute then undergo MRI over 5 minutes at baseline
干预措施: Hyperpolarized Carbon C 13 Pyruvate (Drug)
Cohort A: Single Dose/Image
Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than one minute then undergo MRI over 5 minutes at baseline
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
Cohort B: Multiple Dose/Images
Patients receive hyperpolarized carbon C 13 pyruvate IV over less than one minute then undergo MRI over 5 minutes at baseline and 4 weeks after beginning treatment
干预措施: Hyperpolarized Carbon C 13 Pyruvate (Drug)
Cohort B: Multiple Dose/Images
Patients receive hyperpolarized carbon C 13 pyruvate IV over less than one minute then undergo MRI over 5 minutes at baseline and 4 weeks after beginning treatment
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
结局指标
主要结局
Cohort A: Signal-to-noise Ratio of the Target Lesion 13C Pyruvate Metabolism Measures Will be Determined for Each Patient
时间窗: Baseline
Descriptive statistics will be used to summarize the mean, standard deviation, and 95% confidence interval of the measurements.
Cohort B: Target Tumor Metabolism
时间窗: Up to 4 weeks
Paired t-test or Wilcoxon signed rank test will be used to compare the target tumor Hyperpolarized (HP) 13C pyruvate metabolism pre- and 4-week (+/- 2 weeks) post treatment initiation.
次要结局
- Cohort A: Intraclass Correlation Coefficient (ICC)(Up to 6 months)
- Cohort B: Best Objective Response(Up to 4 weeks after treatment initiation)
研究者
Zhen Wang, MD
Professor in Residence
University of California, San Francisco