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Contrast-Enhanced Ultrasound for Breast Cancer

Phase 2 & 3

Recruiting

Led By Kibo Nam, MD

Research Sponsored by Kibo Nam

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be scheduled for neoadjuvant chemotherapy

If a female of child-bearing potential, must have a negative urine pregnancy test

Must not have

Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia

Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to study completion (48 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial uses CEUS to study if a contrast agent can predict how well breast cancer will respond to neoadjuvant chemotherapy. SHAPE is used to estimate pressure in the tumor and surrounding tissues noninvasively. The study hypothesis is that the subharmonic signal difference in the tumor can predict breast cancer response to NAC after 10% of the therapy regimen.

Who is the study for?

This trial is for adults over 21 with locally advanced breast cancer, scheduled for neoadjuvant chemotherapy, and willing to follow study procedures. It's not for those with other primary cancers, distal metastatic disease, pregnant or nursing women, or individuals with certain heart conditions, recent surgery, unstable cardiopulmonary issues, or allergies to Definity.

What is being tested?

The trial tests if contrast-enhanced ultrasounds using Definity can predict chemotherapy response by measuring pressure in the tumor. This phase II/III trial aims to improve imaging techniques during treatment of locally advanced breast cancer.

What are the potential side effects?

Potential side effects may include allergic reactions to the contrast dye (Definity), which could cause symptoms ranging from mild itching to more severe responses like difficulty breathing or heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for chemotherapy before surgery.

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I am a woman who can have children and my pregnancy test is negative.

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I am at least 21 years old.

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I have been diagnosed with breast cancer that is larger than 2 cm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart rhythm problems.

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I have severe lung problems like emphysema or blood clots in my lungs.

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I do not have severe heart failure that limits my daily activities.

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I have had a recent brain bleed.

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I have another type of cancer that needs treatment through the bloodstream.

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My cancer has spread to distant parts of my body.

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I am not pregnant or nursing.

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I have worsening chest pain due to heart disease.

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I am currently on life support or in a critical care unit.

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I do not have unstable heart or lung conditions.

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I am receiving hormone therapy before surgery for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to study completion (48 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to study completion (48 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to study completion (48 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC)

Prediction of the patients' clinical and pathological response

The ability of the SHAPE method to distinguish responders from non-responders

Secondary study objectives

Accuracy of the 3D SHAPE for predicting locally advanced breast cancer NAC response varies with breast cancer subtype

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (CEUS, Definity)Experimental Treatment3 Interventions

Patients undergo CEUS and receive perflutren lipid microspheres IV over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC. Patients also undergo unenhanced baseline ultrasound imaging before NAC, after 10% of NAC, after 30% of NAC, and after 100% of NAC

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ultrasound

2013

Completed Phase 1

~4090

Contrast-Enhanced Ultrasound

2018

Completed Early Phase 1

~50