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Prostate CancerNCT06636747

High Resolution Diffusion Weighted Imaging in Prostate

An observational study of Prostate Cancer and Prostate Disease, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 55 years and older, men only
Conditions the study is for
Prostate Cancer, Prostate Disease
How many people
500 participants
Where
2 sitesChina
Study dates
1 Aug 2023to 31 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Men larger than 55 years old were eligible to participate if they had a clinical suspicion of PCa with no previous biopsy. This included those with elevated PSA (> 4 ng/ml), or with suspicious digital rectal examination findings, or with suspicious findings on ultrasound examination, or with a family history of PCa.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yu-Dong Zhang contact

86-18251966069

njmu_zyd@163.com

China2 sites, 2 recruiting
  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu

    Yue Wang, 025-68306222, jsphkjwy@163.com

    Recruiting
  • Yu-Dong Zhang

    Nanjing, 210029

    Yu-Dong Zhang, MD;PHD, 15805151704, njmu_zyd@163.com

    Recruiting

Other trials in China

About this study

Official title: A Comparative Study of High Resolution DWI and Conventional DWI in Prostate

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
Read the 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.

Keywords
diffusion weighted imaging, prostate cancer
Medical subject headings
Prostatic Neoplasms, Prostatic Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. image quality evaluation

    objective and subjective image quality and lesion conspicuity

    Measured: 2024.01-2025.12

Secondary outcomes (1)
  1. prostate cancer diagnosis

    the diagnostic accuracy of prostate cancer

    Measured: 2024.01-2025.12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start1 Aug 2023
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06636747
Sponsor's protocol ID
2024-SR-586
Status last verified
Oct 2024
First submitted
8 Oct 2024
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer and Prostate Disease, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yu-Dong Zhang (86-18251966069, njmu_zyd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

image quality evaluation (time frame: 2024.01-2025.12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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