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Contrast-Enhanced Ultrasound for Breast Cancer

Phase 2 & 3

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to study completion (48 months)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (CEUS, Definity)Experimental Treatment2 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contrast-Enhanced Ultrasound

2018

Completed Early Phase 1

~50

Perflutren Lipid Microspheres

2017

Completed Phase 1

~30

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,482 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Kibo NamLead Sponsor

Media Library

Contrast-Enhanced Ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT04715958 — Phase 2 & 3

Breast Cancer Research Study Groups: Diagnostic (CEUS, Definity)

Breast Cancer Clinical Trial 2023: Contrast-Enhanced Ultrasound Highlights & Side Effects. Trial Name: NCT04715958 — Phase 2 & 3

Contrast-Enhanced Ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT04715958 — Phase 2 & 3

Frequently Asked Questions

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

How is Perflutren Lipid Microspheres typically employed?

"Perflutren Lipid Microspheres is most commonly used as part of echocardiography, but it has also been shown to help treat cardiovascular diseases, left ventricular imaging, and other conditions."

Answered by AI

Are people with the necessary qualifications able to enroll in this research project at present?

"This is an ongoing clinical trial that was first posted on December 7th, 2020 according to the website clinicaltrials.gov. The most recent update was made April 25th, 2022."

Answered by AI

How many people can join this clinical trial at the most?

"That is accurate. The most recent update on clinicaltrials.gov reveals that this trial, which was established on December 7th 2020, is still looking for participants. In total, they need 200 patients from 1 location."

Answered by AI

Are Perflutren Lipid Microspheres a new medical treatment?

"There are currently 19 clinical trials studying Perflutren Lipid Microspheres with one in Phase 3. The 26 research centres for these studies are located primarily in Philadelphia, Pennsylvania."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation

Kibo Nam 2020. "Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04715958.

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