A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Participants With Grade 2 or Higher Toxicities
研究概览
简要总结
This early phase I trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance imaging works in detecting lactate and bicarbonate in participants with central nervous system tumors. Hyperpolarized carbon C 13 pyruvate magnetic resonance imaging may be used to measure the metabolic state of malignant brain tumors.
详细描述
PRIMARY OBJECTIVES:
I. To assess the safety of intravenous (IV) injection of hyperpolarized carbon C 13 pyruvate (hyperpolarized [1-13C] pyruvate) for magnetic resonance imaging (MRI).
II. To assess the frequency and sensitivity with which lactate and bicarbonate signals can be detected in malignant brain tumors after IV injection of hyperpolarized [1-13C] pyruvate.
OUTLINE:
Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo magnetic resonance spectroscopic imaging (MRSI) over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
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
- •Patients with a known diagnosis of central nervous system (CNS) malignancy, including metastases, with known enhancement on magnetic resonance (MR) who are otherwise eligible to undergo MRI
- •Glomerular filtration rate (GFR) > 30 ml/min
- •No allergy to gadolinium
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Refusal to have an IV placed for injection
- •Acute major illness (e.g., unstable angina, etc.) or other condition that makes participation unsafe, per the investigator?s judgement
- •Total bilirubin > 1.5 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 x ULN
- •Gamma-glutamyltransferase (GGT) > 2.5 x ULN
- •Pregnant or breast-feeding
- •Cardiovascular risk, including:
- •Poorly controlled hypertension, defined as either systolic > 170 or diastolic > 110
- •Congestive heart failure
- •Myocardial infarction within the past year
- •QT prolongation, defined as pretreatment corrected QT interval (QTc) > 440 msec in males or > 460 msec in females
研究组 & 干预措施
Healthy Volunteers
Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes.
干预措施: Hyperpolarized Carbon C 13 Pyruvate (Drug)
Healthy Volunteers
Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes.
干预措施: Magnetic Resonance Imaging (Procedure)
Healthy Volunteers
Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes.
干预措施: Magnetic Resonance Spectroscopic Imaging (Procedure)
Known CNS Malignancy
Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
干预措施: Gadolinium (Other)
Known CNS Malignancy
Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
干预措施: Hyperpolarized Carbon C 13 Pyruvate (Drug)
Known CNS Malignancy
Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
干预措施: Magnetic Resonance Imaging (Procedure)
Known CNS Malignancy
Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
干预措施: Magnetic Resonance Spectroscopic Imaging (Procedure)
结局指标
主要结局
Number of Participants With Grade 2 or Higher Toxicities
时间窗: 2 days (+/-2) after the scan
The measurement of this drug is the number of participants with Grade 2 or higher related adverse events (except for asymptomatic lab increases)
次要结局
未报告次要终点
研究者
Daniel M. Spielman
Professor of Radiology
Stanford University