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Elasticity Imaging for Breast Cancer

N/A

Recruiting

Led By Elisa Konofagou, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and through neoadjuvant therapy completion (an average of 28 weeks)

Awards & highlights

Study Summary

This trial will study whether a new imaging technique can predict how well a breast cancer patient will respond to neoadjuvant chemotherapy.

Who is the study for?

This trial is for women aged 18 or older with invasive breast cancer of at least 4 mm in size, who are eligible for neoadjuvant systemic therapy. It's not suitable for pregnant or breastfeeding women, those with breast implants, or a history of laser/radiation therapy to the affected breast.Check my eligibility

What is being tested?

The study is testing Harmonic Motion Imaging (HMI), a new imaging technique designed to predict how early-stage breast cancer responds to chemotherapy given before surgery (neoadjuvant chemotherapy).See study design

What are the potential side effects?

Since HMI is an imaging technique and not a drug, it may have fewer side effects compared to medical treatments. However, potential discomfort or risks associated with the procedure will be explained by the research team.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and through neoadjuvant therapy completion (an average of 28 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and through neoadjuvant therapy completion (an average of 28 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and through neoadjuvant therapy completion (an average of 28 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assessment of the correlation between change in HMI measurements and pathologic response at completion of neoadjuvant therapy

Assessment of the correlation between change in HMI measurements and pathologic response during neoadjuvant systemic therapy

Secondary outcome measures

Assessment of correlation between percent change of tumor size on breast ultrasound and pathologic response at treatment completion

Assessment of correlation between percent change of tumor size on breast ultrasound during treatment

Other outcome measures

Assessment of correlation between change in Ki-67 and change in HMI

Trial Design

1Treatment groups

Experimental Treatment

Group I: HMI GroupExperimental Treatment1 Intervention

Women undergoing standard neoadjuvant chemotherapy for breast cancer

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,497 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,310 Patients Enrolled for Breast Cancer

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,783 Total Patients Enrolled

27 Trials studying Breast Cancer

23,449 Patients Enrolled for Breast Cancer

Elisa Konofagou, PhDPrincipal InvestigatorColumbia University

2 Previous Clinical Trials

42 Total Patients Enrolled

Media Library

Harmonic motion imaging Clinical Trial Eligibility Overview. Trial Name: NCT04824027 — N/A

Breast Cancer Research Study Groups: HMI Group

Breast Cancer Clinical Trial 2023: Harmonic motion imaging Highlights & Side Effects. Trial Name: NCT04824027 — N/A

Harmonic motion imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04824027 — N/A

Frequently Asked Questions

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

How many participants have been invited to join this clinical trial?

"Affirmative. According to clinicaltrials.gov, this trial has been live since June 14th 2021 and was last edited on November 7th 2022. The research team is hoping to recruit 50 individuals from a single location."

Answered by AI

Are there any open slots for participants in this trial?

"Clinicaltrials.gov presently attests that this research endeavour is actively recruiting patients, having been initially announced on June 14th 2021 and last updated on November 7th 2022."

Answered by AI

Recent research and studies

IEEE Transactions on Medical ImagingJournal

Feasibility of Harmonic Motion Imaging Using a Single Transducer: In Vivo Imaging of Breast Cancer in a Mouse Model and Human Subjects

Hossain, Md Murad, Niloufar Saharkhiz, and Elisa E. Konofagou. 2021. “Feasibility of Harmonic Motion Imaging Using a Single Transducer: In Vivo Imaging of Breast Cancer in a Mouse Model and Human Subjects”. IEEE Transactions on Medical Imaging. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tmi.2021.3055779.

Ultrasound in Medicine & BiologyJournal

Preliminary Results of Acoustic Radiation Force Impulse (ARFI) Ultrasound Imaging of Breast Lesions

Meng, Wei, Guangchen Zhang, Changjun Wu, Guozhu Wu, Yan Song, and Zhaoling Lu. 2011. “Preliminary Results of Acoustic Radiation Force Impulse (ARFI) Ultrasound Imaging of Breast Lesions”. Ultrasound in Medicine & Biology. Elsevier BV. doi:10.1016/j.ultrasmedbio.2011.05.022.

Scientific ReportsJournal

Harmonic Motion Imaging of Human Breast Masses: An in Vivo Clinical Feasibility

Saharkhiz, Niloufar, Richard Ha, Bret Taback, Xiaoyue Judy Li, Rachel Weber, Alireza Nabavizadeh, Stephen A. Lee, et al.. 2020. “Harmonic Motion Imaging of Human Breast Masses: An in Vivo Clinical Feasibility”. Scientific Reports. Springer Science and Business Media LLC. doi:10.1038/s41598-020-71960-5.

clinicaltrials.govStudy