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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05055843
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
17.7
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Magnetic Resonance Imaging
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:
  1. 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:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Prostate Cancer Without an Endorectal Coil
Actual Study Start Date :
Aug 10, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Screening (3D MRI)

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

Procedure: Magnetic Resonance Imaging
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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Tharakeswara Bathala, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05055843
    Other Study ID Numbers:
    • 2021-0273
    • NCI-2021-05282
    • 2021-0273
    First Posted:
    Sep 24, 2021
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Adenocarcinoma

    Study Results

    No Results Posted as of Aug 22, 2022