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CEUS to Predict Treatment Response in Breast Cancer

Q: Can individuals currently enroll in this experiment?

<p>According to information on clinicaltrials.gov, the study that was initially announced on August 1st 2023 is not presently seeking out participants. However, there are a plethora of other trials actively searching for patients at this time - 2756 in total!</p>

Phase < 1

Recruiting

Led By Seth Hardy, M.D.

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

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

Must have

Age greater than 18yo

Stage I-III TNBC or stage IV TNBC with intact breast primary

Timeline

Screening 3 weeks

Treatment Varies

Follow Up no later than year 5

Awards & highlights

Study Summary

This trial tests if CEUS can be used to detect response to treatment in TNBC patients earlier than regular imaging.

Who is the study for?

This trial is for adults over 18 with Stage I-III Triple Negative Breast Cancer (TNBC) or stage IV TNBC who still have the primary breast tumor. They must be willing to follow study procedures and receive combined Immune Checkpoint Inhibitors therapy as standard care. Pregnant women, those allergic to eggs, or with past reactions to ultrasound contrast agents like PEG can't participate.Check my eligibility

What is being tested?

The study is testing if Contrast Enhanced Ultrasound (CEUS), using a contrast agent called Lumason, can predict how well TNBC patients respond to chemotherapy and immune checkpoint inhibitors sooner than current methods like MR or CT scans.See study design

What are the potential side effects?

Potential side effects from Lumason may include allergic reactions in individuals sensitive to eggs or PEG due to its components. However, this pilot study primarily focuses on the diagnostic capability of CEUS rather than treatment side effects.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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My breast cancer is at an early or locally advanced stage, or it's spread but the primary tumor is still in my breast.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ no later than year 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~no later than year 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and no later than year 5 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline

Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2

Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3

+6 more

Secondary outcome measures

Change in area under the curve (CEUS metric) between Baseline & C2

Change in area under the curve (CEUS metric) between Baseline & C3

Change in area under the curve (CEUS metric) between Baseline & C4

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Contrast Enhanced Ultrasound (with Lumason)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lumason

2015

Completed Phase 4

~390

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

495 Previous Clinical Trials

2,798,854 Total Patients Enrolled

14 Trials studying Breast Cancer

617 Patients Enrolled for Breast Cancer

Seth Hardy, M.D.Principal InvestigatorAssistant Professor - Department of Radiology, Penn State Health

Media Library

Contrast Enhanced Ultrasound (with Lumason) Clinical Trial Eligibility Overview. Trial Name: NCT05957042 — Phase < 1

Breast Cancer Research Study Groups: Contrast Enhanced Ultrasound (with Lumason)

Breast Cancer Clinical Trial 2023: Contrast Enhanced Ultrasound (with Lumason) Highlights & Side Effects. Trial Name: NCT05957042 — Phase < 1

Contrast Enhanced Ultrasound (with Lumason) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05957042 — Phase < 1

Frequently Asked Questions

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

Can individuals currently enroll in this experiment?

"According to information on clinicaltrials.gov, the study that was initially announced on August 1st 2023 is not presently seeking out participants. However, there are a plethora of other trials actively searching for patients at this time - 2756 in total!"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI).

Seth Hardy 2023. "Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05957042.