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

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ClinicalTrials.gov Identifier: NCT05055843
Recruitment Status : Recruiting
First Posted : September 24, 2021
Last Update Posted : February 23, 2023
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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
Prostate Adenocarcinoma Prostate Carcinoma Procedure: Magnetic Resonance Imaging Not Applicable

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:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 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 : August 10, 2021
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05055843


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Tharakeswara Bathala    713-792-2533    tkbathala@mdanderson.org   
Principal Investigator: Tharakeswara Bathala         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Tharakeswara Bathala M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05055843    
Other Study ID Numbers: 2021-0273
NCI-2021-05282 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2021-0273 ( Other Identifier: M D Anderson Cancer Center )
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: February 23, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type