Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

NCT ID: NCT01771497

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Women undergoing neoadjuvant therapy

Koning Breast CT

Intervention Type: DEVICE

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

Interventions

Koning Breast CT

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

Intervention Type: DEVICE

Other Intervention Names

Dedicated breast CT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: collaborator

Koning Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Rochester Medical Center Highland Breast Imaging Center

Rochester, New York, United States

Countries

United States

Other Identifiers

KBCT-005

Identifier Type: -

Identifier Source: org_study_id