Breast Cancer
Conditions
Keywords
Breast CT
Brief summary
The hypothesis of this study is that using Koning Breast CT during the neoadjuvant treatment of breast cancer will allow for accurate tumor localization and tumor volume measurement, leading to improved surgical and radiation therapy outcomes.
Interventions
DEVICEKoning Breast CT
Koning Breast CT scans will be assessed at the beginning, mid-point and end of therapy.
Sponsors
University of Rochester
Koning Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female gender * Age 18 years or older * Any ethnicity * Are undergoing neoadjuvant therapy for locally advanced breast cancer with either chemotherapy or hormonal therapy * Is able to provide informed consent.
Exclusion criteria
* Pregnancy * Lactation * Women who are unable or unwilling to understand or to provide informed consent * Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker. * Women who are unable to tolerate study constraints. * Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to): * Treatment for enlarged thymus gland as an infant * Irradiation for benign breast conditions, including breast inflammation after giving birth * Treatment for Hodgkin's disease * Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. * Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to): * Tuberculosis * Severe scoliosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor volume change from baseline during neoadjuvant treatment | Baseline, mid-point (~3 months), and end of therapy (4-6 months) | Tumor volume will be measured with KBCT imaging at the beginning of the therapy (baseline), mid-point of the therapy (about 3 months after the treatment starts) and end of therapy (about 4-6 months after the treatment starts). The volume change from the baseline during the treatment will be recorded. Adverse Events will be recorded as a measure of safety. |
Countries
United States
Outcome results
None listed