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Koning Breast CT (KBCT)-Guided Neoadjuvant Treatment of Breast Cancer Monitoring Phase I Trial

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Koning Breast CT (KBCT)-Guided Neoadjuvant Treatment of Breast Cancer Monitoring Phase I Trial

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

- 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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Tumor volume change from baseline during neoadjuvant treatment

Outcome Description:

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.

Outcome Time Frame:

Baseline, mid-point (~3 months), and end of therapy (4-6 months)

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

August 2014

Related Keywords:

  • Breast Cancer
  • Breast CT
  • Breast Neoplasms



University of Rochester Medical Center Highland Breast Imaging Center Rochester, New York  14623