← Back to Search

Imaging Agent

Imaging Agent + Ultrasound for Prostate Cancer

Phase 3
Recruiting
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be scheduled for radical prostatectomy for treatment of prostate cancer
Subject must be a male at least 18 years of age when informed consent is obtained
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial will test if perflutren lipid microspheres can be used to safely and effectively diagnose prostate cancer.

Who is the study for?
This trial is for men at least 18 years old who are scheduled for prostate removal due to cancer and can consent to the study. It's not for those with allergies to perflutren or Definity components, severely ill patients, those previously treated for prostate cancer, or anyone in a drug trial within the last month.Check my eligibility
What is being tested?
The study tests if an imaging agent called Definity (perflutren lipid microspheres) combined with ultrasound can help diagnose prostate cancer non-invasively. The agent creates enhanced images by showing up as tiny bubbles on the ultrasound.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to ingredients in Definity like perflutren or PEG. Since it's used briefly and exhaled quickly, long-term side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a surgery to remove my prostate due to cancer.
Select...
I am a man aged 18 or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (perflutren lipid microspheres, ultrasound)Experimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perflutren Lipid Microspheres
2017
Completed Phase 1
~30
Ultrasound
2013
Completed Phase 1
~1950

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
443 Previous Clinical Trials
145,450 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,476 Patients Enrolled for Prostate Cancer

Media Library

Perflutren Lipid Microspheres (Imaging Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05336786 — Phase 3
Prostate Cancer Research Study Groups: Diagnostic (perflutren lipid microspheres, ultrasound)
Prostate Cancer Clinical Trial 2023: Perflutren Lipid Microspheres Highlights & Side Effects. Trial Name: NCT05336786 — Phase 3
Perflutren Lipid Microspheres (Imaging Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05336786 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research opportunity still available to new participants?

"The listing on clinicaltrials.gov does show that the research team is currently looking for participants. This trial was first listed on June 15th, 2022 and has had two updates since then. They are hoping to enroll 50 people total at a single site."

Answered by AI

What are some risks associated with Ultrasound use?

"Ultrasound has received a score of 3 from our Power team. This is based on the fact that it is a Phase 3 trial, meaning that there is both evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

Could you elaborate on how many people are participating in this trial?

"The clinical trial is currently ongoing and looking for 50 patients from 1 site, as stated on clinicaltrials.gov. The trial was originally posted on 6/15/2022 and most recently updated on 6/17/2022."

Answered by AI
~4 spots leftby Jun 2024