Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

January 12, 2016 updated by: Koning Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14623
        • University of Rochester Medical Center Highland Breast Imaging Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women undergoing neoadjuvant therapy
Device: Koning Breast CT
Koning Breast CT scans will be assessed at the beginning, mid-point and end of therapy.
Other Names:
  • Dedicated breast CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, mid-point (~3 months), and end of therapy (4-6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koning Corporation

Collaborators

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 13, 2012

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBCT-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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