Development &Amp; Evaluation of a Quantitative HP MRI Clinical Prostate Cancer Exam
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Reproducibility of the kpl measurement
研究概览
简要总结
This trial examines if a prostate magnetic resonance spectroscopic imaging can be performed on a 3T scanner using an investigational contrast called hyperpolarized 13-C pyruvate for the development of a clinical prostate cancer exam. 3T refers to the strength of the magnetic resonance spectroscopic imaging (MRSI) machine. MRSI is a magnetic resonance imaging (MRI) technique that can show certain chemical differences in healthy and diseased prostate tumor tissue compared to standard multiparametric MRI that may not detect the tumor. Hyperpolarized (HP) 13-C pyruvate is a contrast drug that may help the scanner see the tumor site better during imaging. Hyperpolarization of 13-C pyruvate may allow pyruvate and its metabolites to be detected upon injection, which in turn, allow the prostate cancer to be found and treated.
详细描述
PRIMARY OBJECTIVES:
I. To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including kpl, which assesses the rate of conversion of 13-C pyruvate to 13-C lactate in the tissue of interest, using a test-retest study design.
II. To test the reproducibility of the normalized area under the lactate curve (nLac), a semi-quantitative biomarker for tumor metabolism.
SECONDARY OBJECTIVES:
I. To provide initial assessment of the sensitivity and specificity of hyperpolarized 13-C-pyruvate MRSI performed pre-therapy for detecting high risk localized prostate cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven prostate adenocarcinoma (Arm 1 & 2)
- •Clinically appropriate for active surveillance (Arm 1)
- •Prior prostate biopsy must have been performed at least 5 weeks prior imaging (Arm 1 & 2)
- •Patient must be scheduled to undergo radical prostatectomy within 6 months of multi-parametric magnetic resonance imaging (MP-MRI) + hyperpolarized (HP) [1-13C]-pyruvate imaging, consistent with American College of Radiology Imaging Network (ACRIN) Protocol: ACRIN 6659 (Arm 2)
- •At least 10% of enrolled patients will have high risk of disease progression (Cancer of the Prostate Risk Assessment - [CAPRA] 6-10) and no more than 50% of enrolled patients will have low risk of progression (CAPRA < 3) (Arm 2)
排除标准
- •Contraindication to MRI (Arm 1 & 2)
- •Allergy to gadavist intravenous contrast (Arm 1 & 2)
- •Any known medical history of arrhythmias such as atrial fib, etc. (Arm 1 & 2)
- •Prior therapy for prostate cancer, except for 5-alpha reductase inhibitor discontinued at least one month prior to imaging (Arm 1 & 2)
研究组 & 干预措施
Arm Ia (MRSI)
Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy.
干预措施: Magnetic Resonance Spectroscopic Imaging (Procedure)
Arm Ia (MRSI)
Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy.
干预措施: Hyperpolarized Carbon C 13 Pyruvate (Other)
Arm Ib (MRSI)
Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy and at a second time 3-4 weeks after.
干预措施: Magnetic Resonance Spectroscopic Imaging (Procedure)
Arm II (MRSI, surgery)
Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy, followed by standard of care surgery within 6 months after.
干预措施: Hyperpolarized Carbon C 13 Pyruvate (Other)
Arm Ib (MRSI)
Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy and at a second time 3-4 weeks after.
干预措施: Hyperpolarized Carbon C 13 Pyruvate (Other)
Arm II (MRSI, surgery)
Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy, followed by standard of care surgery within 6 months after.
干预措施: Magnetic Resonance Spectroscopic Imaging (Procedure)
Arm II (MRSI, surgery)
Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy, followed by standard of care surgery within 6 months after.
干预措施: Surgical Procedure (Procedure)
结局指标
主要结局
Reproducibility of the kpl measurement
时间窗: 3 years
Will be assessed using a test-retest study design. Will be summarized by the intra-class correlation coefficient (ICC). Data from patients at both MD Anderson and University of San Fransisco, San Fransisco (UCSF) will be pooled if possible to increase significance. Bland-Altman analysis will be included if the ICC proves unreliable as a measure of reproducibility. ICC is sensitive to data range; thus, Bland-Altman plot, limits of agreement, repeatability coefficient, and the within-patient coefficient of variation (wCV) may be included as appropriate.
Reproducibility of the normalized area under the lactate curve (nLac)
时间窗: 3 years
Will be carried out using data from N=40 patients on active surveillance at MD Anderson. Will be summarized by the ICC. Data from patients at both MD Anderson and University of San Fransisco, San Fransisco (UCSF) will be pooled if possible to increase significance. Bland-Altman analysis will be included if the ICC proves unreliable as a measure of reproducibility. ICC is sensitive to data range; thus, Bland-Altman plot, limits of agreement, repeatability coefficient, and the within-patient coefficient of variation (wCV) may be included as appropriate.
次要结局
- Kpl(3 years)
- Specificity of HP 13-C-pyruvate MRSI for detecting high risk localized prostate cancer(3 years)
- Sensitivity of hyperpolarized (HP) 13-C-pyruvate magnetic resonance spectroscopy imaging (MRSI) for detecting high risk localized prostate cancer(3 years)