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MRI / Ultrasound Fusion With Contrast-Enhanced Ultrasound Guidance

NCT02233725 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-09-08

No results posted yet for this study

Summary

Prostate cancer is the most common cancer in men. It is most often detected by an abnormal digital rectal exam or an elevated Prostate-Specific Antigen -determine by a blood test. When it is suspected that someone may have prostate cancer, a biopsy is ordered. This biopsy is performed by the Radiologist with ultrasound guidance through the rectum. In some patients, a Magnetic Resonance Imaging (MRI) scan of the prostate may be ordered to further evaluate the prostate. In some situations, the MRI and Ultrasound images will be fused (digitally merged) together during the ultrasound procedure to help localize the questionable lesions. Recent research has used an additional component known as a contrast agent - an intravenously injected inert substance - which is identifiable by ultrasound. This inert substance is more obvious in areas of increased blood flow, which is a common finding in cancerous lesions. In this research project, we would like to determine whether the use of contrast-enhanced ultrasound is beneficial in improving accuracy of the biopsies taken and the relative correlation to the MRI/ Ultrasound-fused images.

Conditions

  • Prostatic Neoplasms

Interventions

DEVICE

Definity Perflutren Injectable Suspension

a single dose of 10 μL/kg of the activated product by intravenous bolus injection over 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 μL/kg dose may be administered 5 minutes after the first injection to prolong contrast enhancement

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Christopher Eddy, BSc · VCH

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-07-31
Completion
2015-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02233725 on ClinicalTrials.gov