Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring
Breast Cancer
Conditions: Keywords
Breast CT
Study Type
Study Phase
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Name: Koning Breast CT
Type: Device
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
University of Rochester Medical Center Highland Breast Imaging Center
Rochester, New York, United States
Status: Recruiting
Contact: Rachel Powell, RT - 585-487-3300 - Rachel_Powell@urmc.rochester.edu
Start Date
July 2010
Completion Date
December 2015
Koning Corporation
Koning Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page