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首页> 外文期刊>BMC Medical Imaging >Localising occult prostate cancer metastasis with advanced imaging techniques (LOCATE trial): a prospective cohort, observational diagnostic accuracy trial investigating whole–body magnetic resonance imaging in radio-recurrent prostate cancer
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Localising occult prostate cancer metastasis with advanced imaging techniques (LOCATE trial): a prospective cohort, observational diagnostic accuracy trial investigating whole–body magnetic resonance imaging in radio-recurrent prostate cancer

机译:定位隐匿性前列腺癌转移,具有先进的成像技术(定位试验):预期队列,观察诊断准确性试验,调查无线经复发前列腺癌中的全身磁共振成像

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Accurate whole-body staging following biochemical relapse in prostate cancer is vital in determining the optimum disease management. Current imaging guidelines recommend various imaging platforms such as computed tomography (CT), Technetium 99?m (99mTc) bone scan and 18F-choline and recently 68Ga-PSMA positron emission tomography (PET) for the evaluation of the extent of disease. Such approach requires multiple hospital attendances and can be time and resource intensive. Recently, whole-body magnetic resonance imaging (WB-MRI) has been used in a single visit scanning session for several malignancies, including prostate cancer, with promising results, providing similar accuracy compared to the combined conventional imaging techniques. The LOCATE trial aims to investigate the application of WB-MRI for re-staging of patients with biochemical relapse (BCR) following external beam radiotherapy and brachytherapy in patients with prostate cancer. The LOCATE trial is a prospective cohort, multi-centre, non-randomised, diagnostic accuracy study comparing WB-MRI and conventional imaging. Eligible patients will undergo WB-MRI in addition to conventional imaging investigations at the time of BCR and will be asked to attend a second WB-MRI exam, 12-months following the initial scan. WB-MRI results will be compared to an enhanced reference standard comprising all the initial, follow-up imaging and non-imaging investigations. The diagnostic performance (sensitivity and specificity analysis) of WB-MRI for re-staging of BCR will be investigated against the enhanced reference standard on a per-patient basis. An economic analysis of WB-MRI compared to conventional imaging pathways will be performed to inform the cost-effectiveness of the WB-MRI imaging pathway. Additionally, an exploratory sub-study will be performed on blood samples and exosome-derived human epidermal growth factor receptor (HER) dimer measurements will be taken to investigate its significance in this cohort. The LOCATE trial will compare WB-MRI versus the conventional imaging pathway including its cost-effectiveness, therefore informing the most accurate and efficient imaging pathway. LOCATE trial was registered on ClinicalTrial.gov on 18th of October 2016 with registration reference number NCT02935816.
机译:在前列腺癌中生化复发后准确的全身分期对于确定最佳疾病管理至关重要。目前的成像指南推荐各种成像平台,如计算机断层扫描(CT),99℃(99MTC)骨扫描和18F胆碱和最近的68GA-PSMA正电子发射断层扫描(PET),用于评估疾病程度。这种方法需要多个医院出席,并且可以是时间和资源密集。最近,全身磁共振成像(WB-MRI)已被用于几次访问扫描会议,用于几种恶性肿瘤,包括前列腺癌,与相关的传统成像技术相比提供类似的准确性。定位试验旨在探讨WB-MRI在外部梁放射治疗和前列腺癌患者患者外部横梁放射疗法和近距离放射治疗后重新分期的应用。定位试验是比较WB-MRI和传统成像的预期队列,多中心,非随机,诊断准确性研究。符合条件的患者除了在BCR时的传统成像调查外,还将进行WB-MRI,并被要求参加初步扫描后12个月的WB-MRI考试。 WB-MRI结果将与增强的参考标准进行比较,包括所有初始,后续成像和非成像调查。 WB-MRI对BCR重新分期的诊断性能(敏感性和特异性分析)将根据每位患者的增强参考标准进行调查。将进行与常规成像途径相比的WB-MRI的经济分析,以告知WB-MRI成像途径的成本效益。另外,将对血液样品进行探索性亚研究,并对外泌体衍生的人表皮生长因子受体(她的)二聚体测量用于研究其在该队列中的重要性。定位试验将比较WB-MRI与传统的成像途径,包括其成本效益,从而了解最准确和高效的成像路径。在2016年10月18日的注册参考号NCT02935816将在Clinicaltrial.gov上注册试验.Gov。

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