Breast CancerNCT04824027
Breast Elasticity Imaging During Neoadjuvant Chemotherapy
A study testing Harmonic motion imaging in people with Breast Cancer, run by Columbia University at 1 site in United States.
Trial summary
For this study, the investigators propose investigation of a new imaging technique, Harmonic Motion Imaging (HMI), and the evaluation of its potential role in prediction of breast cancer response to neoadjuvant chemotherapy (NACT). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Harmonic motion imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to May 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age 18 years or older
- Deemed eligible to receive neoadjuvant systemic therapy as per the treating physician, with the dose and schedule deemed appropriate by the treating physician.
- Any stage invasive breast cancer provided the primary breast tumor size is at least 4 mm
Who cannot join
- Patient is pregnant or lactating
- Presence of breast implants
- History of laser or radiation therapy to the affected breast
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center/NYP
New York, New York, 10032
Elisa Konofagou, PhD, 212-342-1612, ek2191@columbia.edu
Ruoxuan Wang, MSc, 212-342-1612, yl4786@columbia.edu
About this study
Official title: Predicting Response to Neoadjuvant Chemotherapy Using Harmonic Motion Imaging in Women With Breast Cancer
For this study, the investigators propose investigation of a new imaging technique, Harmonic Motion Imaging (HMI), and the evaluation of its potential role in prediction of breast cancer response to neoadjuvant chemotherapy (NACT). The investigators hypothesize that changes in HMI parameters will predict response to neoadjuvant systemic therapy in early-stage breast cancer.
Read the detailed description
Neoadjuvant chemotherapy (NACT) is the standard of care for treatment of locally advanced breast cancer (LABC) and inflammatory breast cancer, and is recently being used in earlier stage breast cancer. The ideal outcome of NACT is pathological complete response (pCR), which itself has shown to be associated with improved disease-free survival. However, pCR is currently determined at the time of the surgery when the patient has received the whole cycle of the treatment. Early detection of non-responders to NACT could be used to halt ineffective treatment and start a new chemotherapeutic regimen in order to achieve better tumor response and overall survival. Current techniques to monitor response to NACT based on tumor size changes include mammography, physical examination, ultrasonography and MRI. Clinically assessing tumor size has been shown to be only moderately useful for chemotherapy response prediction in these patients because tumor shrinkage is a late marker of effective treatment. Metabolic activities and microstructure changes induced by NACT can be determined using functional imaging methods such as PET-CT, contrast enhanced MRI and diffuse optical spectroscopy. However, the application of these methods is limited due to high cost and intravenous injection of exogenous contrast agents. Limited studies have shown the potential of ultrasound elastography to be useful in predicting and monitoring response to NACT in breast cancer tumors based on tumor stiffness. Harmonic Motion Imaging (HMI) is a novel ultrasound elastography technique that applies an oscillatory force locally and at different depths in the tissue, in order to determine the characteristics of the resulting localized harmonic motion using high precision tracking methods. Highly localized harmonic motion can be noninvasively generated by ultrasonic beams deep inside the tissue and estimated at high precision, by using RF signals and cross-correlation methods. In addition to not being burdened by the drawbacks encountered by existing techniques, due to the highly localized and harmonic nature of the response, the motion characteristics can be directly linked to the local tissue stiffness. In this study, the investigators propose to compare the changes in the measurements provided by HMI and pathological response rate, between baseline, during treatment and end of the treatment to assess whether HMI can early predict the tumor response to neoadjuvant therapy.
- Conditions
- Breast Cancer
- Being tested
- Harmonic motion imaging
- Keywords
- Breast cancer, Neoadjuvant chemotherapy, Harmonic Motion Imaging (HMI), Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonic motion imagingProcedure or surgery
Also called HMI technique
Harmonic motion imaging (HMI) is a non-invasive ultrasound elasticity imaging technique that yields a quantitative relative measurement of tissue stiffness suitable for comparisons between individuals and over time. This technique induces dynamic tissue vibrations internally for tissue elasticity characterization. Participants will be asked to lie down on their back, hold still with shallow breathing while pictures/images are taken of the breast where the tumor is located using an ultrasound without any invasive procedures.
| Study group | Role | What they receive |
|---|---|---|
| HMI Group | Experimental | Women undergoing standard neoadjuvant chemotherapy for breast cancer Receives: Procedure: Harmonic motion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the correlation between change in HMI measurements and pathologic response at completion of neoadjuvant therapy
- Repeated measures analysis of variance (ANOVA) will be performed to investigate the overall differences in HMI measurements within the tumor and surrounding tissue between responders (pCR and RCB1) and non-responders (RCB2). This relative percent change in tumor stiffness is directly related to HMI measurements.
- Pathologic response will be assessed by the Residual Cancer Burden (RCB) score, a continuous and categorical measure of pathologic response and an independent predictor of disease free survival. Pathologic response will be dichotomized, with response defined as a score of 0-1 (RCB<2), and no response defined as a score of 2-3 (RCB2).
Measured: Baseline and through neoadjuvant therapy completion (an average of 28 weeks)
Assessment of the correlation between change in HMI measurements and pathologic response during neoadjuvant systemic therapy
- Repeated measures analysis of variance (ANOVA) will be performed to investigate the overall differences in HMI measurements within the tumor and surrounding tissue between responders (pCR and RCB1) and non-responders (RCB2). This relative percent change in tumor stiffness is directly related to HMI measurements.
- Pathologic response will be assessed by the Residual Cancer Burden (RCB) score, a continuous and categorical measure of pathologic response and an independent predictor of disease free survival. Pathologic response will be dichotomized, with response defined as a score of 0-1 (RCB<2), and no response defined as a score of 2-3 (RCB2).
Measured: Baseline and during short-interval on treatment (approximately 4 weeks after treatment initiation)
Secondary outcomes (2)
Assessment of correlation between percent change of tumor size on breast ultrasound and pathologic response at treatment completion
The investigator will use the statistic Z=(f1-f2)/se where fi= .5ln[(1+ri)/(1-ri)](Fisher transformation of ri), ri is the sample correlation coefficient of Ri and se is the standard error of f1-f2. The investigator will compare Z with standard normal distribution.
Measured: Baseline and through neoadjuvant therapy completion (an average of 28 weeks)
Assessment of correlation between percent change of tumor size on breast ultrasound during treatment
The investigator will use the statistic Z=(f1-f2)/se where fi= .5ln[(1+ri)/(1-ri)](Fisher transformation of ri), ri is the sample correlation coefficient of Ri and se is the standard error of f1-f2. The investigator will compare Z with standard normal distribution.
Measured: Baseline and during short-interval on treatment (approximately 4 weeks after treatment initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start14 Jun 2021
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Elisa Konofagou, Columbia University
- Investigators
- Elisa Konofagou, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824027
- Sponsor's protocol ID
- AAAT4412
- Other IDs
- R01CA228275
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared with other researchers.
Publications
Saharkhiz N, Ha R, Taback B, Li XJ, Weber R, Nabavizadeh A, Lee SA, Hibshoosh H, Gatti V, Kamimura HAS, Konofagou EE. Harmonic motion imaging of human breast masses: an in vivo clinical feasibility. Sci Rep. 2020 Sep 17;10(1):15254. doi: 10.1038/s41598-020-71960-5.
PubMed 32943648Hossain MM, Saharkhiz N, Konofagou EE. Feasibility of Harmonic Motion Imaging Using a Single Transducer: In Vivo Imaging of Breast Cancer in a Mouse Model and Human Subjects. IEEE Trans Med Imaging. 2021 May;40(5):1390-1404. doi: 10.1109/TMI.2021.3055779. Epub 2021 Apr 30.
PubMed 33523806Meng W, Zhang G, Wu C, Wu G, Song Y, Lu Z. Preliminary results of acoustic radiation force impulse (ARFI) ultrasound imaging of breast lesions. Ultrasound Med Biol. 2011 Sep;37(9):1436-43. doi: 10.1016/j.ultrasmedbio.2011.05.022. Epub 2011 Jul 20.
PubMed 21767903