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临床试验/NCT06244680
NCT06244680已完成不适用

Super-fast 3T Prostate MRI Using High Gradient Strength and Deep Learning: Initial Experience

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
77
试验地点
1
主要终点
Acquisition time

研究概览

简要总结

Recent developments in MRI techniques allow ultra-high gradient strength diffusion imaging and deep learning (DL) reconstruction in clinical routine. However, its usability in biparametric MRI (bpMRI) of the prostate has not been well studied. The aim is to establish a super-fast 3-minutes bpMRI protocol at 3 Tesla using high gradient strength and DL reconstruction and compare it against a full, multiparametric MRI (mpMRI) protocol.

详细描述

Multiparametric MRI (mpMRI) of the prostate has become the most important non-invasive diagnostic tool for assessment of prostate cancer and is the baseline for MRI targeted biopsy (1,2). As the incidence of prostate cancer is high with an estimated 290,000 new cases for 2023 in the United States alone (3), the need for widespread provision of prostate mpMRI is immense. However, current clinical MRI-protocols are long with acquisition times of >30 minutes, potentially limiting the number of examined patients. According to the guidelines of the Prostate Imaging Reporting and Data System (PI-RADS) a sufficient mpMRI protocol must include diffusion weighted imaging (DWI), T2-weighted (T2w) imaging, dynamic contrast enhanced imaging and T1-weighted imaging pre and post administration of contrast (4,5). Different approaches have been developed to shorten the protocol itself or to accelerate acquisition times. For instance, a significant reduction of T2w-sequence acquisition times was achieved by employing deep learning methods (6) or advancements of compressed sensing (7), while at the same time images had improved quality. Different studies showed equal performance of biparametric MRI (bpMRI) protocols compared to the standard multiparametric protocol, effectively reducing the acquisition time down to 5 minutes (8,9,10). This was done by focusing only on DWI and T2w imaging while omitting the dynamic contrast enhanced sequence and T1-weighted sequences, as the additional diagnostic value of these is supposed to be limited (11).

Recent developments in MRI techniques allow for ultra-high diffusion gradient strengths of up to 500 mT/m and slew rates of up to 600 T/m/s, thus reducing echo times and acquisition times by faster establishment of the diffusion gradient (12,13). Furthermore, these gradients are able to image at small scales with a high signal-to-noise ratio, consecutively enhancing sensitivity for detection of tissue microstructures (14,15). Due to the experimental nature of these gradients, this technique has only been investigated in a research setting in healthy volunteers (16), but not in a real world clinical setting, let alone in prostate imaging.

Therefore, the aim of the study was to establish a super-fast abbreviated bpMRI protocol for patients with suspicion for prostate cancer using both ultra-high gradients and deep learning reconstruction for DWI- and T2w-sequences. Besides the assessment of acquisition times, the main objective of this study was to assess the overall image quality of bpMRI and mpMRI and the influence on PI-RADS scores.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Elevated PSA >4ng/ml or suspicious digitial rectal exam or supicious transrectal ultrasound

排除标准

  • General MRI contraindications (incompatible cardiac pacemaker, neurostimulators) or allergy for gadolinium-containing contrast media or severe claustrophobie

结局指标

主要结局

Acquisition time

时间窗: January - February 2024

Acquisition times for the whole biparametric and whole multiparametric protocol was measured.

Agreement of PI-RADS scores

时间窗: January - February 2024

Three radiologists with 3, 11 and 12 years of experience in prostate MRI read separately and blinded to personal and clinical parameters (name, age, patient history, value of the prostate specific antigen, clinical examination and transrectal ultrasound) the full bpMRI protocol and graded the lesions according to the PI-RADS classification. Per patient, only the highest graded lesion and its respective prostate zone was noted. If there were two distinct lesions with the highest PI-RADS score in both the peripheral and transitional zone, both were noted. After a washout period of one month all readers did the same for the mpMRI protocol. Both the agreement of biparametric and multiparametric MRI PI-RADS scores for the whole prostate, and for the specific zonal distribution (peripheral and transitional zone) were assessed by calculation of Cohens's κ, interpreted as follows: \<0.5 = poor; 0.5-0.75 = moderate; 0.75-0.9 = good; \>0.9 = excellent.

Image quality

时间窗: January - February 2024

Two raters with 3 and 11 years of experience rated the bpMRI protocol on a five point Likert scale in six different qualitative categories (artifacts, image sharpness, lesion conspicuity, capsule delineation, overall image sharpness and diagnostic confidence). The grades were defined as follows: 1, non-diagnostic due to extensive artifacts, strongly impaired conspicuity of anatomical structures and no diagnostic confidence; 2, several artifacts, difficult conspicuity of anatomical structures and low diagnostic confidence; 3, moderate artifacts, fair conspicuity of anatomical structures and moderate diagnostic confidence; 4, little artifacts, good conspicuity of anatomical structures and good diagnostic confidence; 5, no artifacts, excellent conspicuity of anatomical structures and high diagnostic confidence. Results of both raters were averaged.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julian Alexander Luetkens

PD Dr. med.; Head of MR-Imaging

University Hospital, Bonn

研究点 (1)

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