Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

Koning Health

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Koning Breast CT

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01771497

KBCT-005

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 1 patient group

Women undergoing neoadjuvant therapy

Treatment:

Device: Koning Breast CT