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Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial) (IMAGINED)

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate Cancer focused on measuring Detection of prostate cancer, software application

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Selected to undergo an MRI-fusion prostate needle biopsy of the prostate. Able to provide informed consent Exclusion Criteria: prior diagnosis of prostate cancer (Grade Group >1) metastatic prostate cancer prior prostate cancer treatment contraindication to prostate biopsy (e.g., on anticoagulation that cannot be safely discontinued) inability to undergo MRI (e.g., too large to be accommodated in a scanner or with an implant incompatible with MRI). Bilateral hip replacement Unable to provide informed consent.

Sites / Locations

  • Audie Murphie VA
  • The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
  • University Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

MRI imaging using Siemens MRI

MRI imaging using Phillips MRI

MRI imaging using General Electric (GE) MRI

Arm Description

Participants enrolled will undergo routine Magnetic Resonance Imaging (MRI) to obtain Restricted Spectrum Mapping (RSM). These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.

Participants enrolled will undergo routine MRI to obtain RSM. These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.

Participants enrolled will undergo routine MRI to obtain RSM. These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.

Outcomes

Primary Outcome Measures

RSM mapping value
Radiologists will report a standard Prostate Imaging, Reporting, and Data System (PI-RADS) and document the RSM values associated with each lesion. Change in value will be reported from baseline to routine biopsy follow-up.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2023
Last Updated
August 8, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05882253
Brief Title
Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)
Acronym
IMAGINED
Official Title
Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to Enhance MRI Diagnostic Capabilities in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Cancer Institute (NCI)

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
The researchers hope to learn if specific types of MRI software and techniques can help improve early prostate cancer detection at time of a MRI-guided prostate biopsy.
Detailed Description
A phase 2 prospective, interventional, non-randomized clinical trial design to investigate whether Restricted Spectrum Maps (RSM) attained from RSI-MRI (On-Q Prostate) improves PI-RADS accuracy compared to PI-RADS alone for the detection of clinically significant prostate cancer. Patients who have agreed to undergo an MRI and subsequent prostate needle biopsy will be approached to participate in the trial. The aims of the study are as follows: Goal 1. Validate RSI-MRI imaging biomarker performance using a prospective clinical trial. Goal 2. Calibrate the RSM values across different MRI scanner manufacturers. Goal 3. Translate RSI using a net clinical benefit model.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Detection of prostate cancer, software application

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients who have agreed to undergo an MRI and subsequent prostate needle biopsy will be approached to participate in the trial. The patient will undergo the prostate MRI as standard of care. The OnQ Prostate will be acquired at the same time as the standard of care MRI at no additional cost to the subject. The MRI images will be acquired using MRI equipment manufactured by 3 different companies, depending on which facility they have their imaging performed.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI imaging using Siemens MRI
Arm Type
Other
Arm Description
Participants enrolled will undergo routine Magnetic Resonance Imaging (MRI) to obtain Restricted Spectrum Mapping (RSM). These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.
Arm Title
MRI imaging using Phillips MRI
Arm Type
Other
Arm Description
Participants enrolled will undergo routine MRI to obtain RSM. These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.
Arm Title
MRI imaging using General Electric (GE) MRI
Arm Type
Other
Arm Description
Participants enrolled will undergo routine MRI to obtain RSM. These sequences are acquired at the same time as standard multi-parametric MRI sequences. Second post-processing software then transfers the acquired RSI images from DICOM format and applies a color-coded image that is then overlayed onto the anatomic T2 image.
Intervention Type
Other
Intervention Name(s)
Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)
Other Intervention Name(s)
On-Q Prostate
Intervention Description
An advanced imaging software that supports improved prostate cancer detection and diagnosis
Primary Outcome Measure Information:
Title
RSM mapping value
Description
Radiologists will report a standard Prostate Imaging, Reporting, and Data System (PI-RADS) and document the RSM values associated with each lesion. Change in value will be reported from baseline to routine biopsy follow-up.
Time Frame
Baseline to approximately 9 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Selected to undergo an MRI-fusion prostate needle biopsy of the prostate. Able to provide informed consent Exclusion Criteria: prior diagnosis of prostate cancer (Grade Group >1) metastatic prostate cancer prior prostate cancer treatment contraindication to prostate biopsy (e.g., on anticoagulation that cannot be safely discontinued) inability to undergo MRI (e.g., too large to be accommodated in a scanner or with an implant incompatible with MRI). Bilateral hip replacement Unable to provide informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A Liss, MD, PhD
Phone
(210) 567-0548
Email
Liss@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brandi Weaver, BA
Phone
210-567-0178
Email
WeaverB@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Liss, MD, PhD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Audie Murphie VA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University Health System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available to other researchers

Learn more about this trial

Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

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