Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02967458
Recruitment Status : Completed
First Posted : November 18, 2016
Results First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prostatic Neoplasm
Intervention Drug: Perflutren Lipid Microsphere Intravenous Suspension
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prostate Biopsy Patients
Hide Arm/Group Description Fifty five 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.
Period Title: Overall Study
Started 55
Completed 55
Not Completed 0
Arm/Group Title Prostate Biopsy Patients
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
  47.3%
>=65 years
29
  52.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
0
   0.0%
Male
55
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Hispanic or Latino
2
   3.6%
Not Hispanic or Latino
53
  96.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   5.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
  18.2%
White
42
  76.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants
55
1.Primary Outcome
Title Percentage of Subjects Whose Prostate Cancer Was Detected With Subharmonic Imaging
Hide Description 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.
Time Frame One week from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1Prostate Biopsy Patients
Hide Arm/Group Description:

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 Intravenous Suspension: The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used

Overall Number of Participants Analyzed 55
Measure Type: Count of Participants
Unit of Measure: Participants
24
  43.6%
2.Primary Outcome
Title Percentage of Biopsy Cores in Which Prostate Cancer Was Detected Using Subharmonic Imaging
Hide Description 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.
Time Frame One week from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prostate Biopsy Patients
Hide Arm/Group Description:

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 Intravenous Suspension: The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used

Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: percentage of biopsy cores
8.33
3.Primary Outcome
Title Percentage of Subjects With Previously Unidentified Prostate Cancer Using Magnetic Resonance Imaging
Hide Description 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.
Time Frame One week from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Thirty one subjects of the total 55 had prior negative MRI or negative MRI guided biopsy
Arm/Group Title Prostate Biopsy Patients
Hide Arm/Group Description:

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 Intravenous Suspension: The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used

Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
9
  29.0%
Time Frame Assessed for 30 minutes post-injection
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prostate Biopsy Patients
Hide Arm/Group Description

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.

Perflutren Lipid Microsphere Intravenous Suspension: The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used

All-Cause Mortality
Prostate Biopsy Patients
Affected / at Risk (%)
Total   0/55 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Prostate Biopsy Patients
Affected / at Risk (%) # Events
Total   0/55 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prostate Biopsy Patients
Affected / at Risk (%) # Events
Total   2/55 (3.64%)    
General disorders   
Throat Tightness *  1/55 (1.82%)  1
Skin and subcutaneous tissue disorders   
Hives *  1/55 (1.82%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ethan Halpern
Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215-955-5345
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02967458     History of Changes
Other Study ID Numbers: 15F.607
R21CA202214 ( U.S. NIH Grant/Contract )
First Submitted: November 16, 2016
First Posted: November 18, 2016
Results First Submitted: November 20, 2018
Results First Posted: May 21, 2019
Last Update Posted: May 21, 2019