3-Tesla MRI for Prostate Cancer

Overseen By Michael Knopp, MD

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Bioimplants, Metallic implants, Claustrophobia, Renal insufficiency, others

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

Compensation: Varies

Number of Visits: 2

280 Participants Needed

Trial Summary

What is the purpose of this trial?

In standard clinical care, the prostate is imaged by magnetic resonance imaging (MRI) which is a procedure to take pictures of body structures by using a strong magnetic field and radio waves. The strength of the magnet used is expressed in the unit Tesla (T); a higher Tesla number means the magnet has stronger pull. Standard magnetic resonance imaging of the prostate uses a magnet 1.5 Tesla strong as well as a specialized endorectal coil (antenna) inserted into the body due to the limitations using an external body coil at this magnet strength. MRI using a 3 Tesla magnet has a theoretical advantage over imaging at 1.5 Tesla of creating a signal twice as strong that can be received by the antennas, resulting in better pictures. The goal of this study is to make the MRI procedure more comfortable for patients by using an external coil instead of an endorectal coil. With this study, researchers also want to help patients' health care teams, the surgeons in particular. Researchers will assess the impact of prostate MRI, without an endorectal coil, done at 3 Tesla and with an external body coil on helping doctors decide which approaches to disease therapy might be best for patients as well as correlate patients' study images with all other clinical imaging

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 data supports the effectiveness of the treatment 3-Tesla MRI for prostate cancer?

Research shows that 3-Tesla MRI provides better image quality and detail compared to the older 1.5-Tesla MRI, which helps in more accurately diagnosing and staging prostate cancer. This improved imaging can lead to better treatment planning and outcomes for patients. ^{1 2 3 4 5}

Is 3-Tesla MRI safe for humans?

The studies primarily focus on the effectiveness of 3-Tesla MRI for detecting prostate cancer, but they do not report any significant safety concerns for humans using this imaging technology. ^{3 6 7 8 9}

How does 3-Tesla MRI differ from other treatments for prostate cancer?

3-Tesla MRI is unique because it offers higher resolution images compared to the more common 1.5-Tesla MRI, which can improve the detection and staging of prostate cancer. This higher resolution is due to an increased signal-to-noise ratio, allowing for more detailed imaging techniques like spectroscopy and diffusion-weighted imaging. ^{4 5 9 10 11}

Research Team

Michael Knopp, MD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for patients with known or suspected prostate cancer, specifically those with a Gleason's score >= 7 and PSA > 10ng/dl. Participants must have proper kidney function (eGFR >= 30 mL/min/1.73m^2). They should be able to follow the study procedures and communicate effectively. Those with severe renal issues, bioimplants like pacemakers, metal in their body, or extreme anxiety are excluded.

Inclusion Criteria

I have prostate cancer with a Gleason score of 7 or higher and a PSA over 10ng/dl.

I will sign a consent form before getting an MRI as per Ohio State University's rules.

My kidney function test shows a filtration rate of at least 30 mL/min.

Exclusion Criteria

I have metal clips or staples from surgery in my body.

I experience significant anxiety or claustrophobia.

I have heart problems or issues with blood circulation and sweating.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 3T MRI, including DCE-MRI, diffusion-weighted MRI, amide-proton-transfer MRI, and MR spectroscopy scans. An additional 3T MRI scan may be performed at least 24 hours after the initial scan.

1-2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

Treatment Details

Interventions

• 3-Tesla magnetic resonance imaging (3T MRI)
• diffusion-weighted magnetic resonance imaging
• dynamic contrast-enhanced magnetic resonance imaging
• magnetic resonance spectroscopic imaging

Trial Overview The trial tests if using a stronger magnet (3 Tesla MRI) without an uncomfortable internal coil can still provide clear images of the prostate for better treatment planning. It compares this method against standard imaging practices to see if it offers more comfort without compromising image quality.

Participant Groups

Group I: Diagnostic (3T MRI) Experimental Treatment 4 Interventions

Patients undergo 3T MRI, including DCE-MRI, diffusion-weighted MRI, amide-proton-transfer MRI, and MR spectroscopy scans. Patients may undergo an additional 3T MRI scan at least 24 hours after the initial scan.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Findings from Research

In a study of 429 patients undergoing 3 Tesla multiparametric MRI before prostatectomy, the use of an endorectal coil did not significantly improve overall prostate cancer detection rates compared to MRI without the coil, with detection rates of 50.5% and 48.2%, respectively.

However, the endorectal coil significantly enhanced the detection of posterior and peripheral prostate cancers, while it was less effective for anterior and transition zone lesions, indicating that the choice of imaging method may influence the detection of specific cancer locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three Tesla Multiparametric Magnetic Resonance Imaging: Comparison of Performance with and without Endorectal Coil for Prostate Cancer Detection, PI-RADS™ version 2 Category and Staging with Whole Mount Histopathology Correlation. Mirak, SA., Shakeri, S., Bajgiran, AM., et al.[2019]

In a study of 122 men with Gleason 6 prostate cancer, transrectal prostate biopsy was found to have a significantly greater temporary negative impact on quality of life compared to prostate multiparametric MRI (mpMRI), with quality of life scores of 0.82 versus 0.95, respectively.

The most notable difference in health impact was related to intraprocedural pain, where biopsy patients reported much higher pain levels than those undergoing mpMRI, indicating that mpMRI may be a safer and less painful option for monitoring prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients. Shankar, PR., Maturen, KE., George, AK., et al.[2020]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Diagnostic value of 3.0 T versus 1.5 T MRI in staging prostate cancer: systematic review and meta-analysis. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Ability of preoperative 3.0-Tesla magnetic resonance imaging to predict the absence of side-specific extracapsular extension of prostate cancer. [2022]

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

Three Tesla Multiparametric Magnetic Resonance Imaging: Comparison of Performance with and without Endorectal Coil for Prostate Cancer Detection, PI-RADS™ version 2 Category and Staging with Whole Mount Histopathology Correlation. [2019]

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

MR imaging of the prostate: 1.5T versus 3T. [2015]

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

Value of 3-T magnetic resonance imaging in local staging of prostate cancer. [2009]

6. Australia pubmed.ncbi.nlm.nih.gov

Prostate cancer in magnetic resonance imaging: diagnostic utilities of spectroscopic sequences. [2015]

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

Initial experience of 3 tesla endorectal coil magnetic resonance imaging and 1H-spectroscopic imaging of the prostate. [2019]

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

Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients. [2020]

9. Australia pubmed.ncbi.nlm.nih.gov

Prostate cancer detection by prebiopsy 3.0-Tesla magnetic resonance imaging. [2019]

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

Update of prostate magnetic resonance imaging at 3 T. [2022]

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

3-T MRI with phased-array coil in local staging of prostatic cancer. [2008]