Recruiting

Breast Elasticity Imaging

Sponsor:

Columbia University

Code:

NCT04824027

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Harmonic motion imaging

Study Details

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

Study ID

NCT04824027

Start date

Jun 14, 2021

Status verified date

May, 2025

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion criteria:

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: HMI Group

Women undergoing standard neoadjuvant chemotherapy for breast cancer

Interventions

Harmonic motion imaging

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.

Primary outcome measure

  • Assessment of the correlation between change in HMI measurements and pathologic response at completion of neoadjuvant therapy [ Time Frame: 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 [ Time Frame: Baseline and during short-interval on treatment (approximately 4 weeks after treatment initiation) ]

Central Contacts and Locations

Central contacts

Elisa Konofagou, PhD

212-342-1612ek2191@columbia.edu

Yangpei Liu, MSc

212-342-1612yl4786@columbia.edu

Locations

Columbia University Irving Medical Center/NYP

Recruiting

New York, New York, United States, 10032

Contacts

Elisa Konofagou, PhD

212-342-1612ek2191@columbia.edu

Yangpei Liu, MSc

212-342-1612yl4786@columbia.edu

Principal Investigator:

Elisa Konofagou, PhD

More Information

Sponsor

Columbia University

Last update posted

May 29, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-05-29.