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Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01771497
First Posted: January 18, 2013
Last Update Posted: January 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Koning Corporation
  Purpose
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.

Condition Intervention
Breast Cancer Device: Koning Breast CT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Koning Breast CT (KBCT)-Guided Neoadjuvant Treatment of Breast Cancer Monitoring Phase I Trial

Resource links provided by NLM:


Further study details as provided by Koning Corporation:

Primary Outcome Measures:
  • 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.



Enrollment: 12
Study Start Date: July 2010
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Dedicated breast CT

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771497


Locations
United States, New York
University of Rochester Medical Center Highland Breast Imaging Center
Rochester, New York, United States, 14623
Sponsors and Collaborators
Koning Corporation
University of Rochester
  More Information

Responsible Party: Koning Corporation
ClinicalTrials.gov Identifier: NCT01771497     History of Changes
Other Study ID Numbers: KBCT-005
First Submitted: December 13, 2012
First Posted: January 18, 2013
Last Update Posted: January 13, 2016
Last Verified: March 2015

Keywords provided by Koning Corporation:
Breast CT

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases