Metabolic Imaging of Patients With Lower Grade Glioma Using Hyperpolarized 13C Pyruvate
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Susan Chang
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of treatment-emergent adverse events (AEs)
研究概览
简要总结
This trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. This study may help researchers learn more about practical ways of evaluating and standardizing treatment in patients with brain tumors.
详细描述
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for making an early assessment of progression and evaluation of response to therapy in patients with lower grade glioma II. To determine whether changes in levels of hyperpolarized 13C pyruvate, lactate and bicarbonate may provide early evidence of tumor progression in patients with lower grade glioma who are being followed with surveillance scans.
III. To determine whether patients with lower grade glioma who are receiving treatment exhibit a reduction in levels of hyperpolarized 13C lactate/pyruvate at follow-up compared to their baseline scan.
OUTLINE: Patients will be enrolled into Cohort 2. Participants previously enrolled in Cohort 1 may enroll in Cohort 2 of study upon re-review of eligibility.
COHORT 1 (CLOSED TO ENROLLMENT): Patients undergo MR imaging (MRI) and MR spectroscopic imaging (MRSI) scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •For patients in cohort 1: histologically proven lower grade glioma who are being followed with surveillance scans
- •For patients in cohort 2: histologically proven glioma who are scheduled for treatment due to suspected residual or recurrent tumor
- •Patients with a life expectancy > 12 weeks
- •Patients must have a Karnofsky performance status of >= 60
- •Patients must have adequate renal function (creatinine < 1.5 mg/dL) before imaging. These tests must be performed within 60 days prior to the hyperpolarized imaging scan.
- •Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
- •Patients must not have New York Heart Association (NYHA) grade II or greater congestive heart failure
- •Patients must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment
- •This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information
- •Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation
- •Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years
- •Patients must not be pregnant or breast-feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of hyperpolarized imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential
排除标准
- •Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures
研究组 & 干预措施
Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT)
Patients undergo MRI and MRSI scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist
干预措施: Magnetic Resonance Imaging (Procedure)
Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT)
Patients undergo MRI and MRSI scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist
干预措施: Magnetic Resonance Spectroscopic Imaging (Procedure)
Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)
Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
干预措施: Hyperpolarized Carbon C 13 Pyruvate (Drug)
Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)
Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
干预措施: Magnetic Resonance Imaging (Procedure)
Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)
Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
干预措施: Magnetic Resonance Spectroscopic Imaging (Procedure)
结局指标
主要结局
Number of treatment-emergent adverse events (AEs)
时间窗: Up to 4 years
Safety evaluation for endpoint will include monitoring for the occurrence of treatment-emergent adverse events (AEs). Reported toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0. All available safety data will be used and will be analyzed using descriptive statistics.
Peak lactate/pyruvate
时间窗: Up to 4 years
The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported.
Peak bicarbonate/pyruvate
时间窗: Up to 4 years
The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported.
Change in peak lactate/pyruvate between scans
时间窗: Baseline up to 4 years
The change in peak lactate/pyruvate between scans will be reported.
Change in peak bicarbonate/pyruvate between scans
时间窗: Baseline up to 4 years
The change in peak bicarbonate/pyruvate between scans will be reported.
次要结局
未报告次要终点
研究者
Susan Chang
Principal Investigator
University of California, San Francisco