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Bubble contrast could reveal prostate cancer without a needle

NCT ID NCT05336786

Diagnosis Sponsor: Thomas Jefferson University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase III trial is testing whether a special ultrasound contrast agent, called Definity, can help doctors see prostate cancer on ultrasound images. The study involves 70 men scheduled for prostate removal surgery. Before surgery, they receive an IV of Definity, which contains tiny gas-filled bubbles that enhance ultrasound images. The goal is to see if this non-invasive method can accurately identify cancer sites in the prostate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Perflutren lipid microspheres (Definity)
What this could lead to
If successful, this could provide a non-invasive way to identify prostate cancer, potentially reducing the need for biopsies.
What could go wrong
This is a small, early-phase study with only 70 participants, and the technique may not be accurate enough to replace standard methods. The contrast agent also carries a small risk of allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

70 people

The number who actually took part.

Started

Jun 2022

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate carcinoma

Contacts and locations

Locations

  • Amsterdam University Medical Centers

    Amsterdam, Netherlands

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

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