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Micro-Ultrasound Imaging for Prostate Cancer

N/A
Recruiting
Led By Geoffrey Sonn
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for MR-US fusion prostate biopsy or radical prostatectomy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of micro ultrasound exam until the date of prostate biopsy data are obtained (average of 7 days
Awards & highlights

Study Summary

This trial uses ultrasound to image the prostate before biopsy or surgery. The images will be used to develop better tools.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves imaging rather than medication, there are no direct side effects from drugs. However, typical risks associated with ultrasound procedures may include discomfort during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a prostate biopsy or complete prostate removal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of micro ultrasound exam until the date of prostate biopsy data are obtained (average of 7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of micro ultrasound exam until the date of prostate biopsy data are obtained (average of 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic accuracy of micro-ultrasound biopsy and prostatectomy patients.
Secondary outcome measures
Location from systematic and targeted cores
Measuring correlation between Prostatectomy pathology and imaging correlation
Morphology of lesions detected by mirco-resolution ultrasound
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ExactVu ImagingExperimental Treatment1 Intervention
EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of: The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex) 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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,374 Previous Clinical Trials
17,332,862 Total Patients Enrolled
22 Trials studying Prostate Cancer
3,886 Patients Enrolled for Prostate Cancer
Geoffrey SonnPrincipal InvestigatorStanford Universiy

Media Library

ExactVu Clinical Trial Eligibility Overview. Trial Name: NCT04981223 — N/A
Prostate Cancer Research Study Groups: ExactVu Imaging
Prostate Cancer Clinical Trial 2023: ExactVu Highlights & Side Effects. Trial Name: NCT04981223 — N/A
ExactVu 2023 Treatment Timeline for Medical Study. Trial Name: NCT04981223 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still possible for this research trial?

"Affirmative. According to the information accessible on clinicaltrials.gov, this medical trial is open for recruitment and was initially published on April 1st 2022 before being revised as recently as June 10th 20202. The study needs 100 patients from a single site to reach its completion."

Answered by AI

Is there a possibility to take part in this experiment?

"This trial is searching for 100 participants, aged between 18 and 89, who are presently undergoing prostate cancer treatment. To be accepted into the study patients must agree to provide informed consent."

Answered by AI

Are any seniors being included in this research?

"The study is open to participants aged 18 and above but under 89 years old."

Answered by AI

How many participants are currently taking part in this research project?

"Yes, the information available on clinicaltrials.gov confirms that this investigation is still recruiting individuals for participation. The trial was initially posted on April 1st 2022 and recently amended on June 10th 2022; the researchers are looking to bring in 100 participants from a single site."

Answered by AI
~34 spots leftby Mar 2025