Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Prostate Cancer Without an Endorectal Coil
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- To be assessed with scoring of quantitative image metrics in regions of prostate cancer and benign tissue
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Screening (3D MRI)
Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time.
Intervention: Magnetic Resonance Imaging (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported