Study of Prostate Perfusion Before Embolization in Patients With Symptomatic Prostate Adenoma. A Single-center Prospective Cohort Pilot Study to Determine the Predictive Factors of Clinical Efficacy Associated With a Prior Phantom Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- MRI perfusion parameters : Time to peak
研究概览
简要总结
Over the last 5 years, prostate embolization has developed as a treatment for symptomatic prostate adenoma. This long, complex procedure is effective in 80% of cases. Currently there are no means of better selecting patients to avoid this long procedure in non-responders. The hypothesis is that prostate perfusion parameters are correlated with the efficacy of embolization. Studying these prostate perfusion parameters in perfusion CT and evaluating prostate Iodine load in dual energy computed tomography will make it easier to select those patients who are most likely to respond.
详细描述
The hypothesis is that there are two types of prostate vascularization in patients with symptomatic prostate adenoma:
- prostates mainly vascularized by large caliber prostate arteries with high flow, for which perfusion parameters in favor of hyper-perfusion will be found. In this case, prostate artery embolization will be effective;
- prostates vascularized by a network of collaterals, with low flow-rates, for which perfusion parameters in favor of hypo-perfusion will be found. In this case, prostate artery embolization will not be very effective.
The purpose of this study is to investigate the association between prostate perfusion parameters (peak time, transit time, blood volume, capillary permeability) and the clinical efficacy of prostate embolization at 3 months. These perfusion parameters could become new biomarkers leading to better selection of patients eligible for efficient prostate embolization, in order to avoid a considerable treatment with no benefit for certain patients and thus limit their global exposure to X-rays during care.
Prior to this prospective study on patients with symptomatic benign prostate hypertrophy, a preliminary experimental study will be performed on a perfusion phantom in order to better understand the differences in the calculation of perfusion parameters according to the three main algorithms used. This will lead to optimization of the prostate perfusion protocol for the scanner: computed tomography acquisition parameters (kilovoltage, Milliamps per second) and therefore the X-ray dose delivered to patients, sampling frequency, and model to be used. The first results of this study have already led to modifications in scanner perfusion acquisition protocols for the initiation of clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The infusion scans will be interpreted by a radiologist who does not know the patient's clinical result in order to avoid a classification bias.
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
- •Patients with symptomatic benign prostatic hypertrophy (prostate volume > 50, IPSS >7, QoL>2) or patients catheterized after acute retention of urine with failed catheterization.
- •Creatinine clearance > 30 mL/min for one of the two Cockcroft-Gault/MDRD equations)
- •Adult patients (≥18 years).
- •Patients with an indication for prostate embolization.
- •Patient with free and informed consent.
- •Patient who have signed the consent form.
- •Patient affiliated or beneficiary of a health insurance plan.
排除标准
- •Hypersensitivity to the active substance or to one of the excipients of the iodized contrast medium.
- •Severe renal impairment with renal function <30mL/min.
- •Contraindication to prostate embolization (aorto-iliac bypass)
- •Patient participating in research defined as Category 1 Research Involving Human Subjects.
- •Patient in an exclusion period as determined by another study.
- •Patient under court protection, guardianship or curatorship.
- •Patient unable to give consent.
- •Patient for whom it is impossible to give informed information.
结局指标
主要结局
MRI perfusion parameters : Time to peak
时间窗: Day 0 (on the day of embolization)
Measured in seconds
MRI perfusion parameters : Extracellular volume
时间窗: 7 - 14 days before embolization
Measured in mL.mL tissue-1
Scanner perfusion parameters : Capillary permeability
时间窗: Day 0 (on the day of embolization)
Measured in mL.mL tissue-1.min-1
Non-catheterized patients: one point improvement in the Global Quality of Life Score.
时间窗: Month 3
Yes/No
Catheterized patients: Removal of the urinary catheter at 3 months
时间窗: Month 3
Yes/No
Non-catheterized patients: 25% decrease in the International Prostate Symptom Score
时间窗: Month 3
Yes/No
MRI perfusion parameters : Prostate iodine load at 80 s.
时间窗: Day 0 (on the day of embolization)
Measured in mgI.mg of prostate-1
MRI perfusion parameters : Capillary permeability
时间窗: 7 - 14 days before embolization
Measured in mL.mL tissue-1.min-1
Scanner perfusion parameters : Extracellular volume
时间窗: Day 0 (on the day of embolization)
Measured in mL.mL tissue-1
MRI perfusion parameters : Blood volume
时间窗: 7 - 14 days before embolization
Measured in mL.mL tissue-1
Scanner perfusion parameters : Blood volume
时间窗: Day 0 (on the day of embolization)
Measured in mL.mL tissue-1
MRI perfusion parameters : Maximum slope
时间窗: 7 - 14 days before embolization
Measured in ml.min-1
Scanner perfusion parameters : Maximum slope
时间窗: Day 0 (on the day of embolization)
Measured in ml.min-1
Scanner perfusion parameters : Prostate iodine load at 80 s.
时间窗: 7 - 14 days before embolization
Measured in mgI.mg of prostate-1
次要结局
- A. Correspondence between MRI and scanner: Blood volume(1 - 7 days before embolization)
- A. Correspondence between MRI and scanner: Maximum slope(1 - 7 days before embolization)
- C. Influence of scanner acquisition parameters: mAs(1 to 15 days before embolization. Preliminary stage on phantom.)
- A. Correspondence between MRI and scanner: Time to peak(1 - 7 days before embolization)
- A. Correspondence between MRI and scanner: 80-second iodine load(1 - 7 days before embolization)
- B. Scanner perfusion parameters : Volume of beads injected(At the time of embolization)
- C. Influence of scanner acquisition parameters: iterative reconstruction(1 to 15 days before embolization. Preliminary stage on phantom.)
- C. Maximum slope(1 to 15 days before embolization. Preliminary stage on phantom.)
- Influence of flow rate on the scanner algorithm(1 - 15 days before embolization. Preliminary stage on phantom.)
- A. Correspondence between MRI and scanner: Capillary permeability(1 - 7 days before embolization)
- B. 4-D map Magnetic Resonance Imaging perfusion parameters : Volume of beads injected(At the time of embolization)
- C. Influence of scanner acquisition parameters: kV(1 to 15 days before embolization. Preliminary stage on phantom.)
- C. Blood volume(1 to 15 days before embolization. Preliminary stage on phantom.)
- A. Correspondence between MRI and scanner: Extracellular volume(1 - 7 days before embolization)
- C. Time to peak(1 to 15 days before embolization. Preliminary stage on phantom.)
