Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Rochester Medical Center Highland Breast Imaging Center

Rochester, New York, 14623, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Koning Breast CT

Device

Koning Breast CT scans will be assessed at the beginning, mid-point and end of therapy.

Other names: Dedicated breast CT

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Koning Corporation

Industry

Collaborators

University of Rochester

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Jan 18, 2013
Registry last updated: Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed