MRI / Ultrasound Fusion With Contrast-Enhanced Ultrasound Guidance

NCT02233725 | Unknown Phase 1

• 1 other identifier: H14-00830
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prostatic Neoplasms; Magnetic Resonance Imaging; MRI / Ultrasound Fusion; Contrast-Enhanced Ultrasound (CEUS)

Outcome Measures

Primary Outcomes (1)

• Measure the quality and pathology results of prostate samples taken during Contrast-Enhanced Ultrasound (CEUS) with MRI/ Ultrasound fusion.

  It is hypothesized that the introduction of the Definity contrast agent during the ultrasound biopsy will increase the accuracy of the targeting biopsy sample, as well as reduce the number of targeted biopsies of non-cancerous lesions. We will compare the MRI characteristics of the prostate lesions in question in real-time ( as the MRI and Ultrasound will be fused together ), and determine whether questionable lesions seen under MRI have increased flow dynamics

  1 Day

Secondary Outcomes (1)

• Measure whether the use of Contrast-Enhanced Ultrasound (CEUS) on prostate cancer detection rates when incorporated with MRI / Ultrasound Fusion differs from non-CEUS prostate biopsies performed under MRI/ Ultrasound Fusion guidance

  1 Day

Other Outcomes (1)

• Generate a Time Intensity Curve for prostate cancer lesions and measure the relation of that value to the MRI Apparent Diffusion Coefficient (ADC) value of the lesion.

  1 month

Study Arms (1)

Definity Perflutren Suspension

ACTIVE COMPARATOR

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.

Device: Definity Perflutren Injectable Suspension

Interventions

Definity Perflutren Injectable Suspension 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

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

Definity Perflutren Suspension

Eligibility Criteria

• Age: 25 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver Coastal Health (VCHRI/VCHA)

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (7)

• Maxeiner A, Fischer T, Stephan C, Cash H, Slowinski T, Kilic E, Durmus T. [Real-time MRI/US fusion-guided biopsy improves detection rates of prostate cancer in pre-biopsied patients]. Aktuelle Urol. 2014 May;45(3):197-203. doi: 10.1055/s-0034-1375682. Epub 2014 Jun 5. German.

  PMID: 24902069 BACKGROUND

• Rifkin MD, Dahnert W, Kurtz AB. State of the art: endorectal sonography of the prostate gland. AJR Am J Roentgenol. 1990 Apr;154(4):691-700. doi: 10.2214/ajr.154.4.1690499. No abstract available.

  PMID: 1690499 BACKGROUND

• Oyen R, Van Popel H, Van de Voorde W, Knapen P, Ameye F, Baert AL, Baert LV. [The significance of focal hypoechoic lesions in the peripheral zone of the prostate]. J Belge Radiol. 1995 Dec;78(6):356-8. Dutch.

  PMID: 8576025 BACKGROUND

• Sibley RI, Sibley AF. Correlation of digital rectal examination, prostate specific antigen, and transrectal ultrasound in prostate carcinoma in African Americans. J Natl Med Assoc. 1997 May;89(5):318-23.

  PMID: 9170832 BACKGROUND

• Norberg M, Egevad L, Holmberg L, Sparen P, Norlen BJ, Busch C. The sextant protocol for ultrasound-guided core biopsies of the prostate underestimates the presence of cancer. Urology. 1997 Oct;50(4):562-6. doi: 10.1016/S0090-4295(97)00306-3.

  PMID: 9338732 BACKGROUND

• Halpern EJ, Ramey JR, Strup SE, Frauscher F, McCue P, Gomella LG. Detection of prostate carcinoma with contrast-enhanced sonography using intermittent harmonic imaging. Cancer. 2005 Dec 1;104(11):2373-83. doi: 10.1002/cncr.21440.

  PMID: 16240450 BACKGROUND

• Mitterberger M, Pinggera GM, Horninger W, Bartsch G, Strasser H, Schafer G, Brunner A, Halpern EJ, Gradl J, Pallwein L, Frauscher F. Comparison of contrast enhanced color Doppler targeted biopsy to conventional systematic biopsy: impact on Gleason score. J Urol. 2007 Aug;178(2):464-8; discussion 468. doi: 10.1016/j.juro.2007.03.107. Epub 2007 Jun 11.

  PMID: 17561137 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Christopher Eddy, BSc

  VCH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 8, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

CA (1)