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

Prostate Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05055843
• Other study ID #: 2021-0273
• Secondary ID: NCI-2021-0528220
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Procedure:
• Magnetic Resonance Imaging
Undergo 3D MRI

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To be assessed with scoring of quantitative image metrics in regions of prostate cancer and benign tissue	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.	through study completion, an average of 1 year

External Links

•   M D Anderson Cancer Center