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OpenTrials
Active, Not Recruiting

NCT Number: NCT05055843

Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Screening Prostate Cancer

This clinical trial studies examines a 3D magnetic resonance imaging (MRI) compared to standard MRI imaging techniques in screening patients with prostate cancer. Diagnostic procedures, such as MRI, may help find and diagnose prostate cancer. Computer systems that allow doctors to create a 3-dimensional (3-D) picture of the tumor may help in planning.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

PRIMARY OBJECTIVE:

I. To determine whether the image quality of the novel 3-dimensional (3D) T2-weighted imaging (T2W) synthetic imaging technique without endorectal coil is comparable to the 2-dimensional (2D) T2W imaging technique without endorectal coil.

SECONDARY OBJECTIVE:

I. To evaluate the qualitative diagnostic quality of the T2W images provided by the novel 3D technique, as determined by subjective scoring by experienced readers.

EXPLORATORY OBJECTIVE:

I. To investigate the feasibility of novel 3D synthetic imaging and multi-spin parameter mapping technique of prostate for the detection of clinically significant prostate cancer (csPCa).

OUTLINE:

Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male, age >= 18
  • Untreated, biopsy-proven with intermediate and high-risk adenocarcinoma of the prostate
  • Patient is being considered for curative-intent treatment with radical prostatectomy
  • Patient has provided written informed consent for participation in this trial
  • Patient should be eligible for scanning on a 3T magnet

Exclusion criteria

  • Low-risk adenocarcinoma of prostate
  • Any prior therapy for prostate cancer
  • A history of other active malignancy within the last 2 years
  • Prostate cancer with significant sarcomatoid, spindle cell, or neuroendocrine small cell components
  • Cardiac pacemaker
  • Orthopedic hardware in the pelvis and spine
  • Claustrophobia

Treatment and study plan

Magnetic Resonance Imaging

Procedure

Undergo 3D MRI

Other names: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Primary outcomes

  1. To be assessed with scoring of quantitative image metrics in regions of prostate cancer and benign tissue

    Time frame: through study completion, an average of 1 year

    Comparing the 2-dimensional (2D) T2W imaging technique without endorectal coil.

    Scored from 1 to 5 with PI-RADS 1 indicating that csPCa is highly unlikely whereas a PI-RADS 5 score indicates that csPCa is highly likely to be present.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Prostate Cancer Without an Endorectal Coil

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2021
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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