Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771497
• Other study ID #: KBCT-005
• Status: Completed
• Phase: N/A
• First received: December 13, 2012
• Last updated: January 12, 2016
• Start date: July 2010
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Koning Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Rochester Medical Center Highland Breast Imaging Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Koning Corporation	University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor volume change from baseline during neoadjuvant treatment	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.	Baseline, mid-point (~3 months), and end of therapy (4-6 months)	Yes