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Diagnostic (contrast agent, CEUS) for Breast Cancer

Phase 1
Recruiting
Led By Bino A Varghese, PhD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years
Newly diagnosed breast masses assigned as BIRADS 4a, 4b, 4c or 5 by conventional US and recommended for ultrasound guided biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial explores using ultrasound to determine if a breast mass is benign or malignant without using radiation. Results could help determine if a biopsy is needed.

Who is the study for?
This trial is for individuals with breast masses that need to be checked if they're benign (not cancer) or malignant (cancer). It's not specified who can't join, but typically those with allergies to the contrast agents used or certain health conditions may be excluded.Check my eligibility
What is being tested?
The study is testing whether a special type of ultrasound called CEUS, using Sulfur Hexafluoride and Perflutren Lipid Microspheres as contrast agents, can help tell apart non-cancerous from cancerous breast lumps without needing a biopsy.See study design
What are the potential side effects?
Potential side effects might include allergic reactions to the contrast agents used in CEUS. These could range from mild itching to more serious reactions like difficulty breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My breast mass is suspicious and needs a biopsy.
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I am female.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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
Performance of radiomics-based ML approach to prevent unnecessary biopsies
Radiomics-based ML-classifier framework

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (contrast agent, CEUS)Experimental Treatment3 Interventions
Patients receive a contrast tracer (Lumason or DEFINITY) IV and then undergo CEUS scan over 60-90 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Contrast-Enhanced Ultrasound
2018
Completed Early Phase 1
~50
Sulfur Hexafluoride Lipid Microspheres
2018
Completed Early Phase 1
~10
Perflutren Lipid Microspheres
2017
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,188 Total Patients Enrolled
12 Trials studying Breast Cancer
4,544 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,066 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Bino A Varghese, PhDPrincipal InvestigatorUniversity of Southern California

Frequently Asked Questions

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

Does this clinical trial have any vacancies?

"According to the records hosted on clinicaltrials.gov, this medical study is actively seeking volunteers. It was initially posted on November 5th 2020 and its most recent update occurred December 5th 2023."

Answered by AI

How many participants is this clinical trial accommodating?

"Affirmative. The information accessible on clinicaltrials.gov confirms that this investigation is recruiting participants; it was first announced on November 5th 2020 and has been updated as recent as December 5th 2023. This experiment aims to find 100 suitable candidates from two separate sites."

Answered by AI

Is CEUS a reliable and safe diagnostic tool?

"There is limited evidence to support the safety and efficacy of Diagnostic (contrast agent, CEUS) so it was given a value of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses
2020. "Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06171607.
~12 spots leftby Nov 2024
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