Breast Elasticity Imaging During Neoadjuvant Chemotherapy

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT04824027
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 14, 2021
Status verified
May 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: HMI Group
    Women undergoing standard neoadjuvant chemotherapy for breast cancer

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center/NYPNew YorkNew York10032
Elisa Konofagou, PhD
212-342-1612
Yangpei Liu, MSc
212-342-1612
Elisa Konofagou, PhD (PRINCIPAL_INVESTIGATOR)

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