Breast Elasticity Imaging During Neoadjuvant Chemotherapy
This study is looking at a new imaging method called Harmonic Motion Imaging (HMI) to see if it can predict how well breast cancer responds to chemotherapy given before surgery (neoadjuvant chemotherapy). Researchers want to see if changes in HMI measurements can show early on if the chemotherapy is working. This could help doctors decide if a different treatment is needed sooner. You may be able to join if you are a woman, 18 or older, have invasive breast cancer at least 4 mm in size, and are scheduled to receive neoadjuvant chemotherapy. The study aims to enroll 50 participants. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 50 women.
- What's involved
- You would have HMI measurements taken at the beginning of your chemotherapy and again about 4 weeks after starting treatment, and then at the completion of your neoadjuvant therapy (around 28 weeks).
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be assessed at the completion of neoadjuvant therapy (an average of 28 weeks).
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Breast Elasticity Imaging During Neoadjuvant Chemotherapy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Elisa Konofagou, PhD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Assessment of the correlation between change in HMI measurements and pathologic response at completion of neoadjuvant therapyBaseline and through neoadjuvant therapy completion (an average of 28 weeks)
* 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).
- Assessment of the correlation between change in HMI measurements and pathologic response during neoadjuvant systemic therapyBaseline and during short-interval on treatment (approximately 4 weeks after treatment initiation)
* 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).