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Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Koning Corporation
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Koning Corporation
ClinicalTrials.gov Identifier:
NCT01771497
First received: December 13, 2012
Last updated: January 16, 2013
Last verified: January 2013
  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) ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 12
Study Start Date: July 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771497

Contacts
Contact: Avice O'Connell, MD (585) 487-3300 avice_oconnell@urmc.rochester.edu

Locations
United States, New York
University of Rochester Medical Center Highland Breast Imaging Center Recruiting
Rochester, New York, United States, 14623
Contact: Rachel Powell, RT    585-487-3300    Rachel_Powell@urmc.rochester.edu   
Sponsors and Collaborators
Koning Corporation
University of Rochester
  More Information

No publications provided

Responsible Party: Koning Corporation
ClinicalTrials.gov Identifier: NCT01771497     History of Changes
Other Study ID Numbers: KBCT-005
Study First Received: December 13, 2012
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Koning Corporation:
Breast CT

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

ClinicalTrials.gov processed this record on November 25, 2014