An Imaging Agent (Perflutren Lipid Microspheres) With Ultrasound for Imaging of Prostate Cancer
Primary Purpose
Prostate Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Perflutren Lipid Microspheres
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Subject must be scheduled for radical prostatectomy for treatment of prostate cancer
- Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate prior to prostatectomy
- Subject must be a male at least 18 years of age when informed consent is obtained
Exclusion Criteria:
- Participant in a clinical trial involving an investigational drug within the past 30 days
- Patients with known or suspected hypersensitivity to perflutren, PEG, or any other component of Definity
- Previous treatment for prostate cancer, including hormone therapy
- Clinically unstable, severely ill, or moribund as per treating physician
Sites / Locations
- Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (perflutren lipid microspheres, ultrasound)
Arm Description
Patients receive perflutren lipid microspheres IV over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres
Outcomes
Primary Outcome Measures
Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate
Secondary Outcome Measures
Full Information
NCT ID
NCT05336786
First Posted
April 7, 2022
Last Updated
June 2, 2023
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT05336786
Brief Title
An Imaging Agent (Perflutren Lipid Microspheres) With Ultrasound for Imaging of Prostate Cancer
Official Title
Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
May 26, 2026 (Anticipated)
Study Completion Date
May 26, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This phase III trial investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively. Definity (perflutren lipid microspheres) is an ultrasound contrast agent that is typically used for ultrasound bubble studies that involve the heart. Definity appears on ultrasound images as tiny gas-filled microbubbles. These microbubbles are about the size of a red blood cell and do not stay in a patient's body for more than several minutes, where they are excreted from the lungs and exhaled back into the air when breathing. Definity may enhance ultrasound images of the prostate and help doctors identify prostate cancer on ultrasound images.
Detailed Description
PRIMARY OBJECTIVES:
I. To collect multiparametric ultrasound (mp-US) data on 50 patients > 3 days prior to radical prostatectomy.
II. To correlate the imaging data with whole mount prostatectomy specimens in order to optimize mp-US with a machine learning approach.
OUTLINE:
Patients receive perflutren lipid microspheres intravenously (IV) over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres during ultrasound.
After completion of study, patients are followed up for 30 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (perflutren lipid microspheres, ultrasound)
Arm Type
Experimental
Arm Description
Patients receive perflutren lipid microspheres IV over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres
Intervention Type
Drug
Intervention Name(s)
Perflutren Lipid Microspheres
Other Intervention Name(s)
Definity
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
Undergo ultrasound
Primary Outcome Measure Information:
Title
Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate
Time Frame
Up to 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must be scheduled for radical prostatectomy for treatment of prostate cancer
Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate prior to prostatectomy
Subject must be a male at least 18 years of age when informed consent is obtained
Exclusion Criteria:
Participant in a clinical trial involving an investigational drug within the past 30 days
Patients with known or suspected hypersensitivity to perflutren, PEG, or any other component of Definity
Previous treatment for prostate cancer, including hormone therapy
Clinically unstable, severely ill, or moribund as per treating physician
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flemming Forsberg, PhD
Phone
215-955-4870
Email
flemming.forsberg@jefferson.edu
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flemming Forsberg, PhD
Phone
215-955-4870
Email
Flemming.Forsberg@jefferson.edu
12. IPD Sharing Statement
Learn more about this trial
An Imaging Agent (Perflutren Lipid Microspheres) With Ultrasound for Imaging of Prostate Cancer
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