Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

NCT01771497 | Completed DMC

• 1 other identifier: KBCT-005
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Breast CT

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Women undergoing neoadjuvant therapy

Device: Koning Breast CT

Interventions

Koning Breast CT DEVICE

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

Also known as: Dedicated breast CT

Women undergoing neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Koning Corporation: lead
• University of Rochester: collaborator

Study Sites (1)

University of Rochester Medical Center Highland Breast Imaging Center

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: January 18, 2013
• Study Start: July 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 13, 2016

Record last verified: 2015-03

Locations

US (1)