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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-10

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Development and Evaluation of a Quantitative HP MRI for Clinical Prostate Cancer Exam

NCT04286386

Prostate Adenocarcinoma

ACTIVE_NOT_RECRUITING

Magnetic Resonance Whole Body Diffusion-Weighted Imaging in Finding Bone or Lymph Node Metastasis in Participants With High-Risk Prostate Cancer

NCT03085043

Prostate Carcinoma

ACTIVE_NOT_RECRUITING NA

An Investigational Scan (MRI With Dixon Based Sequences) in Detecting Prostate Cancer

NCT05047965

Prostate Carcinoma

ACTIVE_NOT_RECRUITING EARLY_PHASE1

MRI in Diagnosing Prostate Cancer

NCT01292291

Prostate Cancer

UNKNOWN NA

Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer

NCT00032058

Prostate Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Adenocarcinoma Prostate Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Screening (3D MRI)

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

Group Type EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo 3D MRI

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnetic Resonance Imaging

Undergo 3D MRI

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No