Micro-Ultrasound Imaging for Prostate Cancer

Overseen By Ned U Realiza

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Does not consent

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on using a new type of ultrasound, called ExactVu, to obtain detailed images of the prostate before a biopsy or surgery. The researchers aim to determine if these images can aid in developing better diagnostic tools for prostate cancer by comparing them with other imaging types and actual surgical findings. Those planning to undergo a biopsy using MR-US fusion or prostate removal surgery might find this trial suitable. Participants must agree to join the study. As an unphased study, this trial offers a unique opportunity to contribute to advancements in prostate cancer diagnosis.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this micro-ultrasound imaging is safe for prostate cancer patients?

Research shows that the ExactVu Micro-Ultrasound system provides detailed imaging of the prostate. The FDA and Health Canada have approved it, confirming it meets safety standards for its intended use. This approval indicates thorough safety checks when used as directed.

Past studies compared the ExactVu system to standard imaging methods, such as MRI, for prostate cancer screening. These studies found no major safety issues, suggesting the procedure is generally well-tolerated. However, as with any medical procedure involving equipment, some discomfort or minor side effects may occur.

Overall, the system's approval in Canada and the U.S. offers reassurance about its safety. Patients should always discuss potential risks with healthcare providers to make informed decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ExactVu Imaging for prostate cancer because it offers a new way to visualize the prostate using micro-ultrasound. Unlike traditional imaging methods like MRI or standard ultrasound, ExactVu provides ultra-high resolution images that can capture greater detail. This precision helps doctors better identify and target suspicious areas for biopsy, potentially leading to earlier and more accurate diagnoses. By improving how we see the prostate, this technique might enhance decision-making and treatment planning for prostate cancer patients.

What evidence suggests that this micro-ultrasound imaging is effective for prostate cancer?

Research has shown that the ExactVu micro-ultrasound system, which participants in this trial will experience, effectively detects significant prostate cancer. Studies have found that this imaging method performs as well as the more commonly used multi-parametric MRI (mpMRI) for identifying important cases of prostate cancer. The ExactVu system provides clear images, aiding doctors in identifying suspicious areas in the prostate more easily. The FDA and other health agencies have approved it, highlighting its reliability and effectiveness. Overall, the ExactVu imaging system is a strong tool for detecting prostate cancer, with promising results. ^{4 6 7 8 9}

Who Is on the Research Team?

Geoffrey Sonn

Principal Investigator

Stanford Universiy

Are You a Good Fit for This Trial?

This trial is for men scheduled to undergo a prostate biopsy or removal due to cancer, who are willing to give their consent. It's not open to those who do not agree to participate.

Inclusion Criteria

Agree to consent to the study

I am scheduled for a prostate biopsy or complete prostate removal.

Exclusion Criteria

Does not agree to consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo micro-ultrasound imaging of the prostate before biopsy or surgery

1 week

1 visit (in-person)

Analysis

Analysis of micro-ultrasound images compared to other imaging modalities and pathology

7 days

Follow-up

Participants are monitored for safety and effectiveness after imaging and analysis

1 year and 10 months

What Are the Treatments Tested in This Trial?

Interventions

• ExactVu

Trial Overview The study is testing the use of a high-resolution micro-ultrasound system called ExactVu. The aim is to capture detailed images of the prostate before biopsy or surgery and compare these with other imaging methods and actual tissue pathology.

How Is the Trial Designed?

Group I: ExactVu Imaging Experimental Treatment 1 Intervention

EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of: 1. The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex) 2. The peripheral zone using the highest zoom setting (30mm depth) on the system (may require 2 sweeps to cover base and apex). Analysis of these images will be performed after surgery but before prostatectomy

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

The ExactVu™ Micro-Ultrasound system is an FDA-approved imaging technology that allows for high-resolution visualization of the prostate, which can aid in the detection of prostate cancer.

In a case study involving a healthy 50-year-old man with no known risk factors, the use of the ExactVu system identified multiple lesions classified as PRI-MUS 3-5, leading to further testing and a diagnosis of significant prostate cancer, highlighting its efficacy in early cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suspicious findings on micro-ultrasound imaging and early detection of prostate cancer. Ghai, S., Van der Kwast, T.[2020]

High resolution micro-ultrasound (micro-u/s) offers a resolution of 70 μm, allowing for detailed visualization of prostate lesions and potentially superior sensitivity for detecting clinically significant prostate cancer compared to mpMRI.

Micro-u/s is a cost-effective and accessible alternative to mpMRI for prostate cancer imaging, with comparable specificity, making it a promising tool for diagnosis in various clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can high resolution micro-ultrasound replace MRI in the diagnosis of prostate cancer? Laurence Klotz, CM.[2021]

In a study of 100 patients with low-risk prostate cancer, micro-ultrasound (microUS) demonstrated high sensitivity (94.1%) for detecting clinically significant cancer (ISUP ≥ 2), making it a valuable tool for monitoring patients on active surveillance.

MicroUS can effectively identify suspicious lesions and may reduce the need for confirmatory biopsies, although it may miss some upgraded cases; it serves as a viable alternative to mpMRI in guiding targeted biopsies for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of microUltrasound at MRI-guided confirmatory biopsy in patients under active surveillance for low-risk prostate cancer. Maffei, D., Fasulo, V., Avolio, PP., et al.[2023]

ExactVuTM, a high-resolution micro-ultrasound system, demonstrated a sensitivity of 74% and specificity of 75% for detecting clinically significant prostate cancer (CsPCa) in the peripheral zone, indicating its potential effectiveness in identifying this type of cancer.

The system showed a positive predictive value (PPV) of 94% for detecting CsPCa in the peripheral zone, suggesting that when ExactVuTM indicates a positive result, it is likely to be accurate, although further studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of the Novel 29 MHz micro-ultrasound "ExactVuTM" for the detection of clinically significant prostate cancer: A prospective single institutional study. A step forward in the diagnosis of prostate cancer. Chessa, F., Schiavina, R., Ercolino, A., et al.[2021]

In a study involving 1676 men, high-frequency micro-ultrasound (micro-US) did not show a significant advantage over conventional ultrasound (conv-US) for detecting clinically significant prostate cancer (csPCa) during prostate biopsies, with detection rates of 34.6% for micro-US and 36.6% for conv-US.

However, after implementing a training protocol for interpreting micro-US images, sensitivity for detecting csPCa improved significantly from 24.6% to 60.8%, indicating that training can enhance the effectiveness of this imaging technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-institutional randomized controlled trial comparing first-generation transrectal high-resolution micro-ultrasound with conventional frequency transrectal ultrasound for prostate biopsy. Pavlovich, CP., Hyndman, ME., Eure, G., et al.[2022]

In a first-in-human study involving 24 patients with prostate cancer, the ultrasound molecular contrast agent BR55 was found to be safe, with no serious adverse events reported during or after its administration.

BR55 successfully detected 50% of malignant lesions identified by histopathology, and with an improved imaging protocol, this detection rate increased to 68%, indicating its potential effectiveness for cancer imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Ultrasound Molecular Imaging With a VEGFR2-Specific Ultrasound Molecular Contrast Agent (BR55) in Prostate Cancer: A Safety and Feasibility Pilot Study. Smeenge, M., Tranquart, F., Mannaerts, CK., et al.[2022]

There is currently no robust data on the long-term effectiveness of high intensity focused ultrasound (HIFU) for treating localized prostate cancer in the United States, which poses challenges for clinical decision-making.

Patient preference data regarding the safety and effectiveness of HIFU treatment for prostate cancer is lacking, highlighting the need for future studies to better inform patients and regulators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Ablation Using High Intensity Focused Ultrasound: A Literature Review of the Potential Role for Patient Preference Information. Babalola, O., Lee, TJ., Viviano, CJ.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12299324/

Micro-Ultrasound in the Detection of Clinically Significant ... Results: Micro-US consistently demonstrated non-inferiority to mpMRI for csPCa detection across retrospective studies, prospective cohorts, and meta-analyses.

2. exactimaging.com exactimaging.com/papers-and-publications

Papers and Posters Listing of published peer-reviewed clinical papers and scientific posters citing the ExactVu micro-ultrasound system for prostate imaging and guided biopsy.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5711692/

Suspicious findings on micro-ultrasound imaging and early ... The ExactVu™ Micro-Ultrasound system is a new high resolution imaging system for visualizing the prostate and has been FDA, CE, and Health Canada approved ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143925000870

Clinical-Prostate cancer Diagnostic performance of high ... The aim of this study was to evaluate the diagnostic outcomes of MRI-ultrasound fusion targeted biopsy in detecting clinically significant prostate cancer ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04981223

Predicting Location and Extent of Prostate Cancer Using ... The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound ...

6. exactimaging.com exactimaging.com/images/manuals/English/ExactVu%20Operation%20and%20Safety%20Manual%20(PN%206746)%20Rev%203.7.pdf

ExactVu High Resolution Micro-Ultrasound System ... ExactVu™ High. Resolution Micro-Ultrasound System is capable of preventing unauthorized access to patient data using password protection. Page 5. Operation and ...

7. exactimaging.com exactimaging.com/exactvu-micro-ultrasound-system

ExactVu™ Micro-Ultrasound System World's first high-resolution transducer enabling unmatched resolution and visualization of the prostate and the surrounding anatomy. Advanced Modes for Multi- ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06626022

NCT06626022 | Screening for Prostate Cancer Using High ... The purpose of this study is to compare whether the FDA and Health Canada approved microUS is as effective as the currently used option (MRI) for imaging the ...

9. mdpi.com mdpi.com/2379-139X/11/7/80

Micro-Ultrasound in the Detection of Clinically Significant ... Exact Imaging Announces Health Canada Approval and License for its ExactVu™ Micro-Ultrasound System for Prostate Imaging and Biopsy-Exact Imaging. Available ...