Detection of High Grade Prostate Cancer With Subharmonic Ultrasound Imaging, A Pilot Study

NCT02967458 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 15F.607R21CA202214JT 8299
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II single center study using contrast-enhanced ultrasound to identify aggressive forms of prostate cancer with subharmonic imaging. The following are the study objectives:

1. 1.To implement subharmonic imaging technology on a transrectal probe suitable for prostate imaging and biopsy
2. 2.To demonstrate visualization of prostatic vascularity using subharmonic contrast-enhanced imaging.
3. 3.To provide a preliminary estimate of the diagnostic accuracy of contrast-enhanced subharmonic imaging for detection of clinically significant PCa.

Conditions

Prostatic Neoplasm

Keywords

prostate cancer; prostate ultrasound; subharmonic imaging; prostate biopsy

Outcome Measures

Primary Outcomes (3)

• Percentage of Subjects Whose Prostate Cancer Was Detected With Subharmonic Imaging

  The initial phase of the trial will develop and test subharmonic imaging to demonstrate enhanced visualization of prostate vascularity in all study participants. We will report the percentage of study subjects in whom visualization of prostate vascularity is increased with subharmonic imaging.

  One week from baseline

• Percentage of Biopsy Cores in Which Prostate Cancer Was Detected Using Subharmonic Imaging

  Study subjects will be scanned with subharmonic imaging during infusion of the microbubble contrast agent. Imaging results will be compared to pathology on prostate biopsy.

  One week from baseline

• Percentage of Subjects With Previously Unidentified Prostate Cancer Using Magnetic Resonance Imaging

  Study subjects will be scanned with subharmonic imaging during infusion of the microbubble contrast agent. Imaging results will be compared to pathology on prostate biopsy.

  One week from baseline

Study Arms (1)

Prostate Biopsy Patients

EXPERIMENTAL

Fifty patients who are scheduled for a clinically indicated prostate biopsy, and who are able to undergo contrast enhanced transrectal ultrasound will be included in this single arm study. Each of the study subjects will receive in intravenous infusion of a microbubble contrast agent known as Definity™, (Perflutren Lipid Microsphere, Lantheus Medical Imaging, Inc; N. Billerica, MA). Based upon our previous experience, two vials of Perflutren Lipid Microsphere will be mixed and diluted in 50 ml of normal saline, yielding a concentration of 49.4 μl/ml. For the purpose of contrast-enhanced imaging, Perflutren Lipid Microsphere will be infused over approximately 10-12 minutes, during which time ultrasound imaging and biopsy will be performed.

Drug: Perflutren Lipid Microsphere Intravenous Suspension

Interventions

Perflutren Lipid Microsphere Intravenous Suspension DRUG

The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used to guide targeted biopsy of the prostate to vascular areas which are more likely to contain aggressive prostate cancer.

Also known as: Definity™ (Lantheus Medical Imaging, Inc; N. Billerica, MA)

Prostate Biopsy Patients

Eligibility Criteria

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

You may qualify if:

• Subject must be scheduled for a clinically indicated needle biopsy of the prostate based upon an elevated PSA, abnormal digital rectal examination, or based upon active surveillance of prostate cancer.
• Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate.
• Subject must be a male at least 18 years of age when informed consent is obtained.
• Subject must have a life expectancy that exceeds the duration of the clinical trial.

You may not qualify if:

• Participant in a clinical trial involving an investigational drug within the past 30 days.
• Prior allergic reaction to the ultrasound contrast agent Definity™
• Previous treatment for PCa.
• Clinically unstable, severely ill, or moribund.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (6)

• Halpern EJ, Gomella LG, Forsberg F, McCue PA, Trabulsi EJ. Contrast enhanced transrectal ultrasound for the detection of prostate cancer: a randomized, double-blind trial of dutasteride pretreatment. J Urol. 2012 Nov;188(5):1739-45. doi: 10.1016/j.juro.2012.07.021. Epub 2012 Sep 19.

  PMID: 22998915 BACKGROUND

• Aigner F, Schafer G, Steiner E, Jaschke W, Horninger W, Herrmann TR, Nagele U, Halpern EJ, Frauscher F. Value of enhanced transrectal ultrasound targeted biopsy for prostate cancer diagnosis: a retrospective data analysis. World J Urol. 2012 Jun;30(3):341-6. doi: 10.1007/s00345-011-0809-6. Epub 2011 Dec 18.

  PMID: 22179312 BACKGROUND

• Trabulsi EJ, Sackett D, Gomella LG, Halpern EJ. Enhanced transrectal ultrasound modalities in the diagnosis of prostate cancer. Urology. 2010 Nov;76(5):1025-33. doi: 10.1016/j.urology.2010.05.022. Epub 2010 Aug 16.

  PMID: 20719368 BACKGROUND

• Nelson ED, Slotoroff CB, Gomella LG, Halpern EJ. Targeted biopsy of the prostate: the impact of color Doppler imaging and elastography on prostate cancer detection and Gleason score. Urology. 2007 Dec;70(6):1136-40. doi: 10.1016/j.urology.2007.07.067.

  PMID: 18158034 BACKGROUND

• Linden RA, Trabulsi EJ, Forsberg F, Gittens PR, Gomella LG, Halpern EJ. Contrast enhanced ultrasound flash replenishment method for directed prostate biopsies. J Urol. 2007 Dec;178(6):2354-8. doi: 10.1016/j.juro.2007.08.022. Epub 2007 Oct 22.

  PMID: 17936814 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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

perflutren

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Ethan Halpern
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

ethan.halpern@jefferson.edu

215-955-5345

Study Officials

• Ethan J Halpern, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Flemming Forsberg, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Radiology

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: February 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: September 20, 2018
• Last Updated: April 30, 2025
• Results First Posted: May 21, 2019

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)