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临床试验/NCT06126172
NCT06126172进行中(未招募)不适用

Radiomics of Treatment-naive Prostate Cancer Patients on Multiparametric MRI for Risk Stratification and Treatment Outcomes Predictions

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2022年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
125
试验地点
1
主要终点
MR characteristics assessment-T2WI

研究概览

简要总结

Prostate cancers (PCA) are a heterogeneous group which include indolent tumors that has no clinical significance to very aggressive cancer that could result in morbidities and mortality. Thus, an accurate risk stratification at the time of PCA diagnosis is crucial. The histological examination of PCA biopsy specimens could not accurately predict the final tumor aggressiveness shown on radical prostatectomy specimens because of heterogeneous distributions of the most malignant tumor cells. Prostate multiparametric magnetic resonance imaging (mpMRI) has been generally accepted to be the best imaging modality for detecting and localizing prostate cancers themselves. Furthermore, the rapid development of radiomics provide comprehensive quantitative information of all tumor data which could be used for risk stratification and prognosis prediction. Thus, this study plans to enroll 200 eligible patients who undergo prostate mpMRI first, followed by radical prostatectomy for prostate cancers. We use radiomics extracted from prostate mpMRI for risk stratification patients of histological aggressiveness as well as to predict very early recurrence of PCA patients within 6 months after radical prostatectomy.

详细描述

Prostate cancer is the 2nd most common malignancy in the world as well as the leading cancer in male population in Taiwan. The treatment selections of prostate cancer are limited by the uncertainty of its aggressiveness (i.e.: histological graded) and staging before treatment. Although prostate mpMRI has much better ability for detection and localization of prostate cancers than other imaging modalities and diagnostic tests, there is still gap for risk stratifications and treatment selection based on prostate mpMRI findings. Thus, a robust radiomics prediction models based on imaging biomarkers on prostate mpMRI with high prediction accuracy could fill the gap of misclassification of risk stratifications of prostate cancers, guides treatment selections and providing monitoring schedules for treated patients as well as early timely additional treatments (i.e.: target therapy or immunotherapy) for patients with high risk of early recurrence. Furthermore, radiomics could provide consistent information which help in decreasing interobserver and intra-observer variability of interpretating prostate cancer even in the use of PIRADS. In this way, this would save the fee of inappropriate or ineffective treatment and avoid unnecessary time and cost of monitoring low risk patients as well as improve patients' survivals and possibly life-quality as well.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Aged over 20 years old.
  • •Suspected or confirmed prostate cancer.
  • •Undergoing prostate mpMRI before clinical treatment.
  • •Normal renal function(i.e.: estimated GFR ≧60).
  • •No allergy history to gadolinium based contrast agent.
  • •Agree to participate this study and sign informed consent.

排除标准

  • •mpMRI photography not completed.
  • •mpMRI images are damaged or poor in quality and cannot be interpreted.
  • •Without pathological examination confirmed prostate cancer.
  • •Patient withdraw informed consent.

研究组 & 干预措施

Multiparametric magnetic resonance imaging

Experimental

Detecting and localizing prostate cancers. The radiomics provide comprehensive quantitative information of all tumor data which could be used for risk stratification and prognosis prediction.

干预措施: Multiparametric magnetic resonance imaging (mpMRI) (Diagnostic Test)

结局指标

主要结局

MR characteristics assessment-T2WI

时间窗: 1.5 year

T2-weighted images (T2WI)

MR characteristics assessment- ADC

时间窗: 1.5 year

Apparent diffusion coefficient maps (ADC)

MR characteristics assessment- DWI

时间窗: 1.5 year

Axial diffusion weighted images (DWI)

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li-Jen Wang

Medical Imaging Department Director

Chang Gung Memorial Hospital

研究点 (1)

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