Contrast-Enhanced Ultrasound for Breast Cancer

Overseen By Kibo Nam, MD

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Thomas Jefferson University

Disqualifiers: Pregnancy, Medically unstable, Cardiac arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies the use of contrast-enhanced ultrasound (CEUS) in estimating tissue pressure in patients with breast cancer. Diagnostic procedures, such as CEUS, may help estimate tissue pressure noninvasively.

Eligibility Criteria

This trial is for adults over 21 with breast cancer who are medically stable and have a mass in the breast suitable for biopsy. They must be able to follow study procedures, not be pregnant or nursing, and have no severe illnesses or recent surgeries.

Inclusion Criteria

Provide signed and dated informed consent form

I am at least 21 years old.

Be medically stable as determined by the investigator

Exclusion Criteria

I am not pregnant or nursing.

I am not critically ill, on life support, or have unstable heart or lung conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Procedure

Patients undergo ultrasound without contrast, receive Definity IV over 15 minutes, and undergo CEUS

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the diagnostic procedure

4 weeks

Treatment Details

Interventions

• Contrast-Enhanced Ultrasound
• Perflutren Lipid Microcpheres
• Ultrasonography

Trial Overview The trial studies how well contrast-enhanced ultrasound can estimate tissue pressure in the breast noninvasively. It involves using an ultrasound with a special contrast agent called Perflutren Lipid Microspheres.

Participant Groups

Group I: Diagnostic (CEUS) Experimental Treatment 3 Interventions

Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.

Contrast-Enhanced Ultrasound is already approved in European Union, United States for the following indications:

Approved in European Union as CEUS for:

• Diagnosis of renal cell carcinoma
• Monitoring of recurrent renal cell carcinoma

Approved in United States as CEUS for:

• Diagnosis of renal cell carcinoma
• Monitoring of recurrent renal cell carcinoma

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+