Breast Cancer Clinical Trial
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center/NYP | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Cancer Institute (NCI) |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assessment of correlation between change in Ki-67 and change in HMI | This will be analyzed using Fisher transformation. | Baseline and through neoadjuvant therapy completion (an average of 28 weeks) | |
Primary | 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) | |
Primary | 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 | 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. | Baseline and through neoadjuvant therapy completion (an average of 28 weeks) | |
Secondary | 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. | Baseline and during short-interval on treatment (approximately 4 weeks after treatment initiation) |
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