RSI-MRI for Early Detection of Prostate Cancer

(IMAGINED Trial)

Recruiting at 2 trial locations

Overseen By Brandi Weaver, BA

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Anticoagulants

Disqualifiers: Prostate cancer, Metastatic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

225 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulation (blood thinners) that cannot be safely stopped, you may not be eligible to participate.

What data supports the effectiveness of the treatment RSI-MRI for early detection of prostate cancer?

Research shows that RSI-MRI, an advanced MRI technique, improves the detection and grading of prostate cancer compared to standard MRI methods. It provides a more accurate way to identify and assess prostate cancer, helping doctors better understand the disease's extent and aggressiveness. ^{1 2 3 4 5}

Is RSI-MRI safe for humans?

The research articles do not provide specific safety data for RSI-MRI, but they focus on its use in detecting prostate cancer, suggesting it is used in clinical settings without reported safety concerns. ^{1 2 3 4 6}

How is the RSI-MRI treatment different from other prostate cancer treatments?

RSI-MRI is a unique imaging technique that enhances standard MRI by using advanced diffusion-weighted imaging to better detect and characterize prostate cancer. It provides a quantitative imaging biomarker called the RSI restriction score, which helps in more accurately identifying and grading prostate cancer compared to conventional MRI methods. ^{1 2 3 4 7}

Research Team

Michael A. Liss

Principal Investigator

University of Texas Health Science Center San Antonio

Eligibility Criteria

This trial is for men selected to undergo an MRI-guided prostate needle biopsy. Participants must be able to understand and agree to the study's procedures by providing informed consent.

Inclusion Criteria

Able to provide informed consent

I am chosen for a specific prostate biopsy using MRI guidance.

Exclusion Criteria

Inability to undergo MRI (e.g., too large to be accommodated in a scanner or with an implant incompatible with MRI)

I cannot safely stop my blood thinner medication for a prostate biopsy.

My prostate cancer has spread to other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Imaging

Participants undergo routine MRI to obtain Restricted Spectrum Mapping (RSM) using different MRI scanner manufacturers

1-2 weeks

1 visit (in-person)

Biopsy and Analysis

Participants undergo MRI-guided prostate biopsy and analysis of RSM values

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in RSM values and PI-RADS accuracy from baseline to routine biopsy follow-up

9 months

Treatment Details

Interventions

• Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI)

Trial Overview The IMAGINED Trial is testing if advanced MRI software, called Restricted Spectrum Imaging-MRI (RSI-MRI), can improve early detection of prostate cancer during a biopsy procedure.

Participant Groups

Group I: MRI imaging using Siemens MRI Experimental Treatment 1 Intervention

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.

Group II: MRI imaging using Phillips MRI Experimental Treatment 1 Intervention

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.

Group III: MRI imaging using General Electric (GE) MRI Experimental Treatment 1 Intervention

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.

Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI) is already approved in United States, European Union for the following indications:

Approved in United States as RSI-MRI for:

• Prostate cancer detection
• Prostate cancer imaging in men on active surveillance

Approved in European Union as RSI-MRI for:

• Prostate cancer detection
• Prostate cancer imaging

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The novel restriction spectrum imaging (RSI-MRI) technique significantly outperformed standard MRI in detecting extraprostatic extension (EPE) in prostate cancer patients, identifying EPE in 89% of cases compared to only 22% with standard MRI.

This study involved 28 prostate cancer patients, and the results suggest that RSI-MRI could greatly enhance the accuracy of prostate cancer imaging, warranting further research for its clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel technique for characterizing prostate cancer utilizing MRI restriction spectrum imaging: proof of principle and initial clinical experience with extraprostatic extension. Rakow-Penner, RA., White, NS., Parsons, JK., et al.[2018]

The study evaluated 100 patients, including 67 with confirmed prostate cancer, and found that combining restriction spectrum imaging (RSI) with multi-parametric MRI (MP-MRI) significantly improved the detection of high-grade prostate cancer, achieving higher diagnostic accuracy (AUC of 0.78 vs. 0.70 for sextant level).

RSI used alongside T2-weighted imaging (T2WI) provided similar detection rates for high-grade prostate cancer as MP-MRI alone, indicating that RSI can be a valuable tool in prostate cancer diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restriction spectrum imaging improves MRI-based prostate cancer detection. McCammack, KC., Schenker-Ahmed, NM., White, NS., et al.[2018]

In a study of 33 patients with prostate cancer, the novel restriction spectrum imaging (RSI-MRI) technique showed a superior ability to differentiate cancerous tissue from normal tissue compared to standard diffusion MRI, achieving an area under the ROC curve (AUC) of 0.94 versus 0.85.

RSI-MRI also outperformed conventional MRI in predicting the aggressiveness of prostate cancer, with a significant correlation to tumor grade, indicating its potential to enhance diagnosis and characterization of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo prostate cancer detection and grading using restriction spectrum imaging-MRI. McCammack, KC., Kane, CJ., Parsons, JK., et al.[2022]

Restriction spectrum imaging (RSI) provides a quantitative biomarker, the RSI restriction score (RSIrs), which significantly improves the detection of clinically significant prostate cancer (csPCa) compared to traditional methods like the apparent diffusion coefficient (ADC). In a study of 151 patients, RSIrs achieved an area under the curve (AUC) of 0.78, indicating strong performance in identifying csPCa.

The combination of RSIrs and the Prostate Imaging Reporting and Data System (PI-RADS) scores resulted in an even higher AUC of 0.85, suggesting that using both methods together is more effective than using either one alone for detecting csPCa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Patient-level Prostate Cancer Detection with Quantitative Diffusion Magnetic Resonance Imaging. Zhong, AY., Digma, LA., Hussain, T., et al.[2023]

Magnetic resonance imaging (MRI) significantly improves the staging and characterization of prostate cancer compared to traditional methods like clinical evaluation and CT scans, allowing for better assessment of tumor location and extent.

The combination of MRI with dynamic contrast-enhanced MRI (DCE-MRI) and MR spectroscopic imaging (MRSI) provides critical prognostic information that can guide personalized and minimally invasive treatment strategies for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer imaging. Fuchsjäger, M., Shukla-Dave, A., Akin, O., et al.[2022]

In a study of 198 biopsy-naïve men, restriction spectrum imaging (RSI) demonstrated comparable diagnostic performance to conventional diffusion-weighted imaging (DWI) for detecting clinically significant prostate cancer, with overall accuracies of 0.70 for RSI and 0.68 for DWI.

RSI showed better specificity for detecting prostate cancer in the transition zone compared to DWI, indicating that RSI may be particularly useful for identifying lesions in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Restriction Spectrum Imaging Among Men Undergoing First-Time Biopsy for Suspected Prostate Cancer. Felker, ER., Raman, SS., Shakeri, S., et al.[2020]

Restriction spectrum imaging (RSI) is a new MRI technique that can quickly provide detailed information about tissue microarchitecture in less than 5 minutes, making it a promising tool for prostate cancer detection and characterization.

RSI enhances the ability to localize disease by combining water diffusion data with high-resolution T2-weighted images, improving the delineation of cancer spread into important anatomical areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restriction spectrum imaging: An evolving imaging biomarker in prostate MRI. Brunsing, RL., Schenker-Ahmed, NM., White, NS., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Novel technique for characterizing prostate cancer utilizing MRI restriction spectrum imaging: proof of principle and initial clinical experience with extraprostatic extension. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Restriction spectrum imaging improves MRI-based prostate cancer detection. [2018]

3. England pubmed.ncbi.nlm.nih.gov

In vivo prostate cancer detection and grading using restriction spectrum imaging-MRI. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Automated Patient-level Prostate Cancer Detection with Quantitative Diffusion Magnetic Resonance Imaging. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Prostate cancer imaging. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Utility of Restriction Spectrum Imaging Among Men Undergoing First-Time Biopsy for Suspected Prostate Cancer. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Restriction spectrum imaging: An evolving imaging biomarker in prostate MRI. [2022]