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简化双参数磁共振成像用于前列腺癌筛查的诊断准确性:一项前瞻性可行性研究(ReIMAGINE研究)

Diagnostic accuracy of abbreviated biparametric MRI for prostate cancer screening: a prospective feasibility study (ReIMAGINE study).

作者信息

Thorley Natasha, Parry Tom, Giganti Francesco, Kopcke Douglas, Sidhu Harbir S, Brembilla Giorgio, Stallard Emma, Emberton Mark, Moore Caroline M, Punwani Shonit

机构信息

Centre for Medical Imaging, University College London, London, UK.

Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK.

出版信息

Eur Radiol. 2025 Aug 6. doi: 10.1007/s00330-025-11837-1.

DOI:10.1007/s00330-025-11837-1
PMID:40770137
Abstract

OBJECTIVES

To evaluate the diagnostic accuracy and imaging findings of an abbreviated biparametric MRI (bpMRI) protocol for prostate cancer (PCa) screening.

MATERIALS AND METHODS

In this single-centre, prospective study, men aged 50-75 years were randomly selected for invitation to screening through participating general practices. Participants underwent screening with abbreviated bpMRI (axial T2-weighted and b2000 diffusion-weighted sequences) and PSA testing between October 2019 and December 2020. Screening MRIs were independently reported by two radiologists as either positive or negative by screening criteria, with a third radiologist if there was disagreement. Positive MRI or raised PSA density (PSAd) (≥ 0.12 ng/mL) triggered standard-of-care NHS PCa assessment. Outcomes of the NHS assessment were collated as a composite reference standard and included multiparametric MRI ± biopsy, and a 2-year healthcare record follow-up. Diagnostic accuracy was evaluated using positive predictive value (PPV).

RESULTS

Among 303 men who completed screening (median age 62 years [IQR 56, 68]), 16% (48/303) had a positive screening MRI, and an additional 5% (16/303) had raised PSAd alone. Of 61 men referred to secondary care, 48% (29/61) had clinically significant PCa, with 2 (3%, 2/61) additional diagnoses during 2-year follow-up. Of 31 men with clinically significant PCa, 87% (27/31) had a positive screening MRI and 42% (13/31) had raised PSAd. The PPV of the screening MRI was 59% (27/46, 95% CI: 44, 72).

CONCLUSION

Abbreviated bpMRI may have value in PCa screening independently of PSA testing. However, prospective multicentre evaluation is needed to assess the feasibility and cost-effectiveness of MRI-based screening at a national level.

KEY POINTS

Question MRI may reduce over- and under-diagnosis from prostate-specific antigen (PSA) testing in PCa screening, but its use is limited by long scan times, cost, and availability. Findings Abbreviated bpMRI identified more men with clinically significant cancer than PSAd (≥ 0.12 ng/mL), with a PPV of 59% (95% CI: 44, 72). Clinical relevance Prostate MRI may improve cancer detection independently of PSA testing, with abbreviated protocols enhancing feasibility and scalability. While MRI may offer an opportunity for early diagnosis, further prospective, multicentre evaluation is needed to explore its potential role in screening settings.

摘要

目的

评估一种简化的双参数MRI(bpMRI)方案用于前列腺癌(PCa)筛查的诊断准确性和影像学表现。

材料与方法

在这项单中心前瞻性研究中,随机选择年龄在50 - 75岁的男性,通过参与的全科诊所邀请他们进行筛查。参与者在2019年10月至2020年12月期间接受了简化的bpMRI(轴位T2加权和b2000扩散加权序列)筛查以及PSA检测。筛查MRI由两名放射科医生根据筛查标准独立报告为阳性或阴性,如有分歧则由第三名放射科医生进行判断。MRI阳性或PSA密度(PSAd)升高(≥0.12 ng/mL)会触发英国国家医疗服务体系(NHS)的PCa标准评估。NHS评估的结果被整理为一个综合参考标准,包括多参数MRI ± 活检,以及为期2年的医疗记录随访。使用阳性预测值(PPV)评估诊断准确性。

结果

在303名完成筛查的男性中(中位年龄62岁[四分位间距56, 68]),16%(48/303)的筛查MRI为阳性,另外5%(16/303)仅PSAd升高。在转诊至二级医疗机构的61名男性中,48%(29/61)患有临床显著性PCa,在2年随访期间又有2例(3%,2/61)确诊。在31名患有临床显著性PCa的男性中,87%(27/31)的筛查MRI为阳性,42%(13/31)的PSAd升高。筛查MRI的PPV为59%(27/46,95%可信区间:44, 72)。

结论

简化的bpMRI可能在PCa筛查中具有独立于PSA检测的价值。然而,需要进行前瞻性多中心评估,以评估基于MRI的筛查在国家层面的可行性和成本效益。

关键点

问题MRI可能减少PCa筛查中前列腺特异性抗原(PSA)检测导致的过度诊断和漏诊,但其应用受到扫描时间长、成本高和可及性的限制。研究结果简化的bpMRI比PSAd(≥0.12 ng/mL)能识别出更多患有临床显著性癌症的男性,PPV为59%(95%可信区间:44, 72)。临床意义前列腺MRI可能独立于PSA检测改善癌症检测,简化方案提高了可行性和可扩展性。虽然MRI可能提供早期诊断的机会,但需要进一步的前瞻性多中心评估来探索其在筛查环境中的潜在作用。

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