MRI / Ultrasound Fusion With Contrast-Enhanced Ultrasound Guidance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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It is the hypothesis that cancerous lesions in the prostate will have an increased amount of blood flow, and that the lesions identified under ultrasound with the benefits of contrast-enhanced imaging can be correlated to the MRI Findings in real-time. A study of 50 patients who would be undergoing MRI/Ultrasound fusion would be selected to have contrast added to their procedure. The lesions identified on MRI would then be evaluated with contrast-enhanced ultrasound. The findings from the contrast study could then be correlated with the MRI findings. The rest of the prostate gland would also be assessed using the contrast agent for lesions not identified on the MRI imaging study. The pathology results could be correlated with both the contrast study and the MRI study both independently, and in conjunction with the two imaging modalities. If a correlation between highly suspicious lesions on the MRI and significant flow patterns under contrast can be established, then the sensitivity and specificity of contrast-enhanced ultrasound can be increased.

While MRI / Ultrasound Fusion is being shown to increase prostate cancer identification and targeting for biopsy, it is a very limited modality due to the costs associated. Many sites will also not have access to an MRI unit, and the fusion system is prohibitively expensive, and requires specialized training to configure the system and modulate the images in real-time. However, ultrasound is an in expensive modality that is readily available. If the materials and methods in the utilization of contrast-enhanced ultrasounds can be correlated to MRI / Ultrasound fusion, better protocols can be developed for contrast-enhanced ultrasound. This more cost-effective method of identifying and targeting prostate cancer could then be exported to smaller communities who would otherwise still be carrying out the sextant biopsy model.

Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Definity Perflutren Suspension

Injection of Definity Perflutren Injectable Suspension- which travels in the bloodstream throughout the body. These microbubbles are identifiable on ultrasound imaging, and studies of the liver and kidney have identified it as a useful adjunct to identifying vascular lesions. Areas of regular blood flow will not have as large a concentration of the microbubble agent as will areas that have increased blood flow and neovascularisation. It has been well documented that cancerous solid lesions undergo neovascularisation and have increased blood flow to the area.

Group Type ACTIVE_COMPARATOR

Definity Perflutren Injectable Suspension

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Lantheus DEFINITY FDA Application No. - (NDA) 021064 Active Ingredient(s) - PERFLUTREN Strength- 6.52MG/ML Dosage Form/Route - INJECTABLE;INTRAVENOUS

Eligibility Criteria

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Inclusion Criteria

* Adults ( aged 21 years or greater), English speaking patients

Exclusion Criteria

* Patients who are unable to provide informed consent
* Patients who have had previous reaction to any contrast agent at any point in the past
* Patients who have had previous septic infection from prostate biopsies at any point in the past
* Patients who have a right-to-left, bi-directional, or transient right-to-left cardiac shunts.
* Patients undergoing extracorporeal shock wave lithotripsy for urinary calculi.
* Patients with pre-existing cardiopulmonary compromise including, but not limited to, acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias or respiratory failure, including patients receiving mechanical ventilation

Minimum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No