Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

Completed

• Conditions: Breast Cancer
• Interventions: Device: Koning Breast CT

• Registration Number: NCT01771497
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Status Verified: 2015-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women undergoing neoadjuvant therapy	Koning Breast CT	-

Primary Outcome Measures

Name	Time	Method
Tumor volume change from baseline during neoadjuvant treatment	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.

Trial Locations

Locations (1)

University of Rochester Medical Center Highland Breast Imaging Center; 🇺🇸 Rochester, New York, United States