RSI MRI for Prostate Cancer
(ART-Pro Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new MRI techniques to better detect significant prostate cancer without the usual drawbacks. Typically, detecting prostate cancer with MRI requires a special dye and an expert radiologist. The trial aims to use two new MRI methods that could enable regular radiologists to find cancer just as effectively. It seeks men already scheduled for a prostate MRI due to cancer suspicion and who meet specific criteria, such as not having any metal implants.
As an unphased study, this trial provides a unique opportunity to contribute to advancements in prostate cancer detection technology.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these advanced MRI techniques are safe for detecting prostate cancer?
This trial explores new MRI methods to detect prostate cancer. While specific safety data for these new MRI techniques is not yet available, MRI (Magnetic Resonance Imaging) is a common and trusted imaging method. It is generally safe because it doesn't use harmful radiation like X-rays.
The trial employs two methods: biparametric MRI (bpMRI) and Restriction Spectrum Imaging (RSI). These aim to detect cancer more effectively without some drawbacks of current methods, such as the need for IV contrast, which can sometimes cause allergic reactions. Notably, bpMRI doesn't require IV contrast.
Since these are variations of existing MRI techniques, and given MRI's history of safety, these methods are expected to be well-tolerated. However, like any medical procedure, some risks or discomforts may occur. Discuss any concerns with the trial team or your doctor.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the potential of biparametric MRI and advanced, quantitative diffusion MRI to enhance prostate cancer detection. Unlike traditional methods like PSA tests or standard MRI scans, these advanced imaging techniques aim to provide more precise and detailed views of prostate tissue. This could lead to earlier and more accurate diagnosis, potentially improving treatment outcomes and reducing unnecessary biopsies. By using advanced imaging, the hope is to make prostate cancer detection less invasive and more reliable.
What evidence suggests that these MRI techniques are effective for detecting clinically significant prostate cancer?
Research has shown that biparametric MRI (bpMRI) and the Restriction Spectrum Imaging restriction score (RSIrs) can detect significant prostate cancer without requiring IV contrast dye. Studies have found that these advanced MRI methods enable non-specialist radiologists to achieve accuracy comparable to expert radiologists. This accuracy is crucial for identifying prostate cancer that requires treatment. By eliminating the need for IV contrast, these methods could make screening safer and more comfortable for patients. Early evidence suggests that RSIrs alone might effectively identify significant prostate cancer. Overall, these techniques aim to enhance cancer detection while reducing the need for expert interpretation and contrast dyes.678910
Who Is on the Research Team?
Tyler Seibert, MD, PhD
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
ART-Pro-1
Prospective evaluation of bpMRI, mpMRI, and RSIrs techniques by expert radiologists
ART-Pro-2
Retrospective evaluation of MRI techniques by radiologists of varying experience levels
Follow-up
Participants are monitored for medical outcomes such as biopsy results or surgery pathology
What Are the Treatments Tested in This Trial?
Interventions
- RSI MRI
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Massachusetts General Hospital
Collaborator
GE Healthcare
Industry Sponsor
Fotis Vlachos
GE Healthcare
Chief Marketing Officer since 2024
PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania
Peter J. Arduini
GE Healthcare
Chief Executive Officer since 2022
MBA from Northwestern University, BSc in Marketing from Susquehanna University
Cambridge University Hospitals NHS Foundation Trust
Collaborator
University of California, San Francisco
Collaborator
Weill Medical College of Cornell University
Collaborator
Citations
ART-Pro: Clinical Trial Evaluating Biparametric MRI and ...
It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...
Trial Protocol Advanced Restriction Imaging and ...
ART-Pro-1 will evaluate bpMRI, mpMRI, and RSIrs on the accuracy of expert radiologists' detection of csPCa and will evaluate RSIrs as a stand-alone, ...
Advanced Restriction Imaging and Reconstruction ...
ART-Pro is a multisite, multinational trial that aims to evaluate whether IV contrast can be avoided in the setting of standardized, state-of-the-art image ...
ART-Pro: Clinical Trial Evaluating Biparametric MRI and ...
This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate ...
ART-Pro: Clinical Trial Evaluating Biparametric MRI and ...
This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate cancer (csPCa).
SAFETY DATA SHEET
RESPONSE: P301+P312 IF SWALLOWED: Call POISON CETNER and/or doctor if you feel unwell. P302+P352 IF ON SKIN: Wash with plenty of soap and water.
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Safety Data Sheet
Signal word. Danger. Hazard statement. May be corrosive to metals. Causes severe skin burns and eye damage. Precautionary statement. Prevention.
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