RSI-MRI for Early Detection of Prostate Cancer

(IMAGINED Trial)

Recruiting at 3 trial locations

Overseen By Jessica Warbrick, ND

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Diego

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a special type of MRI, called RSI-MRI (Restricted Spectrum Imaging-Magnetic Resonance Imaging), can detect prostate cancer earlier during a biopsy. Researchers use various MRI machines to determine if the imaging method performs better with certain equipment. Men scheduled for an MRI-guided prostate biopsy who have never received treatment for prostate cancer might be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance early detection of prostate cancer.

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 prior data suggests that this MRI technique is safe for early prostate cancer detection?

Research shows that Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI) effectively detects early-stage, aggressive prostate cancer. It can identify cancer at an early stage. In past studies, RSI-MRI, when combined with regular MRI methods, has proven more accurate in detecting prostate cancer than standard methods alone.

Regarding safety, MRI, including RSI-MRI, is generally safe. It doesn't use radiation, a common concern with other imaging methods. Research has not reported any major side effects, indicating that patients tolerate the procedure well. Computer software enhances the images without posing any known physical risk to participants.

Overall, evidence suggests RSI-MRI is a safe and promising tool for early prostate cancer detection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about RSI-MRI for early detection of prostate cancer because it offers a more precise imaging technique compared to traditional MRI methods. Unlike standard multiparametric MRI, RSI-MRI uses a restricted spectrum mapping approach that enhances image clarity by reducing noise and highlighting abnormal tissues more effectively. This method overlays color-coded images onto anatomical scans, potentially improving the accuracy of prostate cancer detection and allowing for earlier and more reliable diagnoses. By refining how we visualize prostate tissue, RSI-MRI could lead to better-targeted treatments and improved outcomes for patients.

What evidence suggests that this trial's MRI techniques could be effective for early prostate cancer detection?

Research has shown that a special type of MRI, called Restricted Spectrum Imaging-Magnetic Resonance Imaging (RSI-MRI), holds promise for early detection of prostate cancer. Studies have found that RSI-MRI effectively identifies aggressive prostate cancer before it spreads. This trial will compare different MRI imaging systems, including General Electric (GE), Siemens, and Phillips, to obtain RSI-MRI images. This imaging method helps doctors locate prostate cancer more accurately than standard techniques. Clinical guidelines suggest that using advanced MRI methods like RSI-MRI before a biopsy can improve the detection of significant prostate cancer. This makes RSI-MRI an exciting tool in the fight against prostate cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael A. Liss

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5386962/

Restriction spectrum imaging improves MRI-based prostate ... In summary, RSI shows promise for PCa detection and localization, statistically improving the ability of readers to localize disease when used in combination ...

2. auajournals.org auajournals.org/doi/10.1097/JU.0000000000001692

Restriction Spectrum Imaging-Magnetic Resonance ... Restriction spectrum imaging is highly sensitive and specific for detecting early stage, aggressive prostate cancer. The PI-RADS® scoring system ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04992728

Prostate Assessment with Restriction Spectrum Imaging ... Several advanced MRI models will be applied to the data, and the models will be assessed for accurate prediction of grade group ≥2 prostate cancer on ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666168324014344

Trial Protocol Advanced Restriction Imaging and ... Clinical guidelines strongly recommend multiparametric magnetic resonance imaging (mpMRI) prior to biopsy to improve the detection of clinically significant ...

5. news.uthscsa.edu news.uthscsa.edu/ut-health-san-antonio-study-shows-mri-technique-improves-detection-of-aggressive-prostate-cancer/

UT Health San Antonio study shows MRI technique ... An MRI scan called restriction spectrum imaging greatly improves the detection of prostate cancer progression, according to a published study.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33617334/

Restriction Spectrum Imaging-Magnetic Resonance ... - PubMed Our objective is to investigate the utility of restriction spectrum imaging-magnetic resonance imaging to improve upgrading detection in a ...

7. urologytimes.com urologytimes.com/view/prostate-mri-solution-onq-prostate-launches-on-us-market

Prostate MRI solution OnQ Prostate launches on US market One study showed that RSI with mpMRI improved prostate cancer detection vs mpMRI alone (85% accuracy vs 79% accuracy; P = 0.04) ...