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

Primary Purpose

Prostate Adenocarcinoma, Prostate Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Imaging
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening (3D MRI)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2021
Last Updated
October 5, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05055843
Brief Title
Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Screening Prostate Cancer
Official Title
Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Prostate Cancer Without an Endorectal Coil
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma, Prostate Carcinoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening (3D MRI)
Arm Type
Experimental
Arm Description
Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time.
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo 3D MRI
Primary Outcome Measure Information:
Title
To be assessed with scoring of quantitative image metrics in regions of prostate cancer and benign tissue
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tharakeswara Bathala
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tharakeswara Bathala
Phone
713-792-2533
Email
tkbathala@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Tharakeswara Bathala

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

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