Breast Elasticity Imaging During Neoadjuvant Chemotherapy

NCT04824027 | Recruiting

• 2 other identifiers: AAAT4412R01CA228275
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). The investigators hypothesize that changes in HMI parameters will predict response to neoadjuvant systemic therapy in early-stage breast cancer.

Conditions

Breast Cancer

Keywords

Breast cancer; Neoadjuvant chemotherapy; Harmonic Motion Imaging (HMI); Ultrasound

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  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

  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

  Baseline and during short-interval on treatment (approximately 4 weeks after treatment initiation)

Other Outcomes (1)

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

  Baseline and through neoadjuvant therapy completion (an average of 28 weeks)

Study Arms (1)

HMI Group

EXPERIMENTAL

Women undergoing standard neoadjuvant chemotherapy for breast cancer

Procedure: Harmonic motion imaging

Interventions

Harmonic motion imaging PROCEDURE

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.

Also known as: HMI technique

HMI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age ≥18
• 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 ≥ 4 mm

You may not qualify if:

• Patient is pregnant or lactating
• Presence of breast implants
• History of laser or radiation therapy to the affected breast

Sponsors & Collaborators

• Columbia University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Columbia University Irving Medical Center/NYP

New York, New York, 10032, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 32943648 BACKGROUND

• Hossain 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.

  PMID: 33523806 BACKGROUND

• Meng 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.

  PMID: 21767903 BACKGROUND

Related Links

• Ultrasound Elasticity Imaging Laboratory - Columbia University

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elisa Konofagou, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Konofagou, PhD

CONTACT

212-342-1612; ek2191@columbia.edu

Yangpei Liu, MSc

CONTACT

212-342-1612; yl4786@columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Robert and Margaret Hariri Professor in Biomedical Engineering and Radiology

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: April 1, 2021
• Study Start: June 14, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)