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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Prostate Carcinoma; Prostate Adenocarcinoma

Treatments: Procedure: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT05055843

2021-0273 (Other Identifier)

NCI-2021-05282 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment: 33 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Screening (3D MRI)

Experimental group

Description:

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

Treatment:

Procedure: Magnetic Resonance Imaging