Menu
Recruiting NCT06636747

High Resolution Diffusion Weighted Imaging in Prostate

Observational Prostate Cancer Prostate Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Prostate Cancer, Prostate Disease. Basic parameters: from 55 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Comparative Study of High Resolution DWI and Conventional DWI in Prostate

Overview

hrDWI might be an alternative to cDWI for the prostate imaging. 1. increase the signal-to-noise ratio and contrast-to-noise ratio, yielding high-fidelity images with less noise in general 2. improve the diagnostic accuracy of PCa in particular than conventional DWI

Detailed description

Magnetic Resonance Imaging (MRI) with the Prostate Imaging Reporting and Data System (PI-RADS) is a state-of-the-art strategy, not only for standardizing prostate MRI scanning, but also for PCa detection, diagnosis and staging. In PI-RADS score evaluation, diffusion weighted imaging (DWI) is an important component of the prostate MRI examination, which is considered to be the dominant sequence for the assessment of lesions in the peripheral zone (PZ) and is also regarded as the auxiliary sequence for the upgrade of lesions in the transitional zone (TZ). DWI reflects the random motion of water molecules, that should include high b-value images (at least b≥1400s/mm²) and an calculated ADC map. As the b-value increases, DWI enables detection of small changes because of better contrast between malignant and background tissue. Meanwhile, the problems arise. DWI is often plagued by poor spatial resolution, distortion, and artifacts, as well as decreased signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR). This is a major obstacle to the application, interpretation, and ultimate impact of prostate MRI. Improving the quality of DWI images would be helpful in lesion orientation and detection of small cancers.Recently, a novel denoising technique, that operating on repetitively acquired MRI data and only removing components that cannot be distinguished from zero-mean Gaussian distributed noise, has been proposed for acquisition of ultra-high resolution images. Recent studies have shown that ultra-high resolution images significantly improvements in temporal-SNR, the detection and reproducibility of stimulus-induced signal changes, and the accuracy of images. Based on reconstruction algorithms with trainable components, high resolution DWI (hrDWI) can increase the SNR and CNR, yielding high-fidelity images with less noise in general, and thus to improve the diagnostic accuracy of PCa in particular than conventional DWI (cDWI).Therefore, we made the hypothesis that hrDWI might be an alternative to cDWI for the prostate imaging. The purpose of this study includes two aspects: 1) compare objective and subjective image quality and lesion conspicuity of hrDWI with cDWI in prostate MRI; 2) test the non-inferiority of hrDWI in terms of PCa diagnosis against cDWI in a cohort of suspcious patients.

Primary outcome measures

  • image quality evaluation [Time frame: 2024.01-2025.12]
Secondary outcome measures (1)
  • prostate cancer diagnosis [Time frame: 2024.01-2025.12]

Eligibility criteria

Inclusion criteria

  • Patients who underwent standard MR scanning including T2WI, cDWI , hrDWI and respective calculated apparent diffusion coefficient (ADC) maps;
  • Complete clinical information.

Exclusion criteria

Men were excluded if they were using 5-alpha-reductase inhibitors at time of examination or has used such during the previous six months; or if they had a previous history of prostatic biopsy, prostatic surgery, or treatment for PCa

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 2 centers
  • The First Affiliated Hospital with Nanjing Medical University — Nanjing
  • Yu-Dong Zhang — Nanjing

Identifiers

NCT: NCT06636747 · 2024-SR-586

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗