Clinical trial · Interventional
Breast Elasticity Imaging During Neoadjuvant Chemotherapy
Predicting Response to Neoadjuvant Chemotherapy Using Harmonic Motion Imaging in Women With Breast Cancer
NCT04824027CI-TRIAL-00090302recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Harmonic motion imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HMI Group
- description
- Women undergoing standard neoadjuvant chemotherapy for breast cancer
- interventionNames
- Procedure: Harmonic motion imaging
Primary outcomes (2)
- measure
- Assessment of the correlation between change in HMI measurements and pathologic response at completion of neoadjuvant therapy
- timeFrame
- Baseline and through neoadjuvant therapy completion (an average of 28 weeks)
- description
- * 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDSaharkhiz 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
- BACKGROUNDHossain 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
- BACKGROUNDMeng 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