Hyperpolarized 13-C-Pyruvate Magnetic Resonance Spectroscopic Imaging Reproducibilty Pilot in Patients With Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Reproducibility of the key performance indicator
研究概览
简要总结
This phase II trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance spectroscopic imaging works in predicting treatment response in patients with prostate cancer. Hyperpolarized carbon C 13 pyruvate magnetic resonance spectroscopic imaging may help to accurately predict how prostate cancer patients will respond to standard therapy (abiraterone and apalutamide).
详细描述
PRIMARY OBJECTIVE:
I. To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including key performance indicator (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.
SECONDARY OBJECTIVE:
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.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven high risk prostate adenocarcinoma, or de novo metastatic previously untreated naive prostate cancer (patients who have initiated gonadotrophin releasing hormone [Lhrh] analog or antagonist within the past 4 weeks are eligible)
- •Gleason >= 8 OR Gleason 7 + >= cT2b + prostate specific antigen (PSA) > 10 ng/ml
- •Prior prostate biopsy must have been performed at least 4 weeks prior
排除标准
- •Contraindication to MRI
- •Estimated glomerular filtration rate (eGFR) < 30
- •Allergy to gadavist intravenous contrast
- •History of cardiac arrhythmia
- •Since they do not get prostate cancer, women are excluded; thus, pregnancy is not an issue
研究组 & 干预措施
Diagnostic (hyperpolarized carbon C 13 pyruvate MRSI)
Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.
干预措施: Hyperpolarized Carbon C 13 Pyruvate (Drug)
Diagnostic (hyperpolarized carbon C 13 pyruvate MRSI)
Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.
干预措施: Magnetic Resonance Spectroscopic Imaging (Procedure)
结局指标
主要结局
Reproducibility of the key performance indicator
时间窗: Up to 3 years
次要结局
- Sensitivity assessed by comparison to biopsy(Up to 3 years)
- Specificity assessed by comparison to biopsy(Up to 3 years)