Harmonic motion imaging for Breast Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Columbia University Irving Medical Center/NYP, New York, NY
Breast Cancer+1 More
Harmonic motion imaging - Procedure
Eligibility
18+
Female
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a new imaging technique may help predict breast cancer response to chemotherapy.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Harmonic motion imaging will improve 2 primary outcomes, 2 secondary outcomes, and 1 other outcome in patients with Breast Cancer. Measurement will happen over the course of Baseline and during short-interval on treatment (approximately 4 weeks after treatment initiation).

Week 4
Assessment of correlation between percent change of tumor size on breast ultrasound during treatment
Assessment of the correlation between change in HMI measurements and pathologic response during neoadjuvant systemic therapy
Week 28
Assessment of correlation between change in Ki-67 and change in HMI
Assessment of correlation between percent change of tumor size on breast ultrasound and pathologic response at treatment completion
Assessment of the correlation between change in HMI measurements and pathologic response at completion of neoadjuvant therapy

Trial Safety

Trial Design

2 Treatment Groups

Control
HMI Group

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Harmonic Motion Imaging is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

HMI Group
Procedure
Women undergoing standard neoadjuvant chemotherapy for breast cancer
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and through neoadjuvant therapy completion (an average of 28 weeks)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and through neoadjuvant therapy completion (an average of 28 weeks) for reporting.

Who is running the study

Principal Investigator
E. K.
Prof. Elisa Konofagou, Robert and Margaret Hariri Professor in Biomedical Engineering and Radiology
Columbia University

Closest Location

Columbia University Irving Medical Center/NYP - New York, NY

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient is able to receive neoadjuvant systemic therapy as prescribed by the doctor, with the dose and schedule decided by the doctor. show original
Any stage of invasive breast cancer as long as the primary breast tumor size is ≥ 4 mm. show original
Women age ≥18

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does breast cancer run in families?

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Findings from a recent study from this large and multiethnic cohort analysis suggest that breast cancer risk is not directly related to genetic risk factors. Additional SNPs with larger effect sizes may be identified by future research on these loci to further explain the genetic risk factors in breast cancer.

Unverified Answer

How many people get breast cancer a year in the United States?

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During 2010, 1,632,960 women were diagnosed with breast cancer. Of those diagnosed, 783,769 survived to 5 years (95.75% of population). Overall death-adjusted survival is 89%. This is the greatest of any year in all of the 20th century. Survival data from 2010 is not yet available.

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Can breast cancer be cured?

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There is very little evidence to support a 'cure' in breast cancer. There are real benefits of screening, in terms of preventing deaths and disease recurrence. The evidence to support any specific treatment for breast cancer seems to be limited, although there are some good examples. In particular, chemotherapy and surgery are effective means of treating breast cancer, with high rates of cure if the tumour is small and well-defined. However, no good evidence demonstrates that 'cure' for breast cancer can be achieved. More importantly, the evidence does not support any claim that 'cure' for breast cancer is possible in principle.

Unverified Answer

What are common treatments for breast cancer?

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Different types of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s present differing patterns of treatment, but no significant differences between age or geographic region for cancer treatment. Chemotherapy and endocrine drug therapy are commonly used to treat breast cancer. When breast cancer is more advanced, surgery may be the only option.

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What are the signs of breast cancer?

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Symptoms of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) are commonly described as a lump or a sore. Other symptoms include itchiness, feeling unsteady, feeling tired and pain (which may be worse at night, with sleep or with certain activities). These symptoms may be related with cancer. Symptoms can be classified as mastalgia, which affects most of healthy women, and breast tenderness. In the future symptoms of breast cancer could be detected by a blood test or by an imaging test called Mammogram or Ultrasound scanning. A screening program could reduce the number of women who choose not to have a mammogram. At present women can have a mammogram as a part of routine medical check-up and also in case of symptoms or suspiciousness of breast cancer.

Unverified Answer

What is breast cancer?

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Most new [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s occur in women 55 and over. This group is most often the first to have had a screening mammogram. Most of these screenings begin within 1 year of being screened for the first time. Breast cancer prevention by mammography is a well established method; however, screening participants have increased breast cancer rates over time, although for certain subgroups such as those who had not been screened over the past 10 years, there does not appear to be any increase in lifetime rates. A limitation of the study is that data are from the same hospital in which both cancer groups were treated, but this is likely to have a minimal influence on the results.

Unverified Answer

What causes breast cancer?

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The most recent evidence suggests that the increase in [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) incidence may be related more to environmental factors, rather than changing genetic factors than changing the frequency of invasive cancers. In North America, mammography screening started in the 1970s has led to a 50% reduction in breast cancer incidence in young and middle-aged women. Although not all mammography can be justified, this screening program has saved countless women with early breast cancer from unnecessary amputations and suffering from a poorer quality of life.\n

Unverified Answer

What are the chances of developing breast cancer?

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The odds are higher for women with a family history of breast cancer compared to those without a family history. The chance of developing breast cancer is higher amongst women with fewer babies and more older siblings. The chances of developing breast cancer are significantly lower in a female who doesn't have a baby after 10 years of age.

Unverified Answer

Have there been other clinical trials involving harmonic motion imaging?

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As an adjunct to traditional 3D imaging, HMI has shown promise as a diagnostic modality for the detection of recurrent disease as confirmed by core biopsy, but has yet to achieve similar sensitivity or specificity as traditional 3D imaging.

Unverified Answer

How quickly does breast cancer spread?

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The early tumor cells that form our metastases have a high motility velocity comparable to that of normal cells. But after that cell has left the primary tumor, they show slower rates of movement. The high mobility and invasive capacity of the initial tumor suggest that these high-velocity cells are the most likely to initiate metastasis. The slower rate of movement seen in the cell population from the second tumor formation point is an indication for the concept of a micro-environment, similar on both cellular and extracellular levels, as a more favorable site for metastatic tumor cell proliferation and invasion and therefore of an unfavorable outcome with respect to survival.

Unverified Answer

What is the average age someone gets breast cancer?

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Breast cancer occurs in men as well as women, and the average age of men who develop breast cancer is around 60 years. Women's average age is around 50 years. Men and women have the same average age that they get breast cancer at around 50.0. (Source: Cancer Management, Cancer Research. 2005. Oct;70(10):2937-42)

Unverified Answer

Does harmonic motion imaging improve quality of life for those with breast cancer?

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Harmonic motion images for free 3-D reconstruction of 2D mammographic images does not improve QoL and subjective parameters of QoL for individuals with early stage breast cancer.

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