Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01771497
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : January 13, 2016
University of Rochester
Information provided by (Responsible Party):
Koning Corporation

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.

Condition or disease Intervention/treatment
Breast Cancer Device: Koning Breast CT

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Koning Breast CT (KBCT)-Guided Neoadjuvant Treatment of Breast Cancer Monitoring Phase I Trial
Study Start Date : July 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
Women undergoing neoadjuvant therapy Device: Koning Breast CT
Koning Breast CT scans will be assessed at the beginning, mid-point and end of therapy.
Other Name: Dedicated breast CT

Primary Outcome Measures :
  1. Tumor volume change from baseline during neoadjuvant treatment [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Twelve female patients at least 18 years of age undergoing neoadjuvant therapy for locally advanced breast cancer with either chemotherapy or hormonal therapy will be recruited for this study. Inclusion of those patients 18 years or older is important since as it is the younger patients who present with breast cancer that often end up receiving neoadjuvant treatment.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01771497

United States, New York
University of Rochester Medical Center Highland Breast Imaging Center
Rochester, New York, United States, 14623
Sponsors and Collaborators
Koning Corporation
University of Rochester

Responsible Party: Koning Corporation Identifier: NCT01771497     History of Changes
Other Study ID Numbers: KBCT-005
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: March 2015

Keywords provided by Koning Corporation:
Breast CT

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases