Cone Beam Computed Tomography for Breast Imaging (CBCTBI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Koning Corporation
ClinicalTrials.gov Identifier:
NCT00972413
First received: September 3, 2009
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

The primary aim of this study is to investigate the use of cone beam computed tomography (CBCT) for breast imaging in the diagnostic setting by providing a compelling body of evidence incorporating both non-contrast and contrast enhanced CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions.


Condition Intervention Phase
Breast Cancer
Radiation: Computed Tomography
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cone Beam Computed Tomography for Breast Imaging and IV Contrast Enhanced Cone Beam Computed Tomography Breast Imaging

Resource links provided by NLM:


Further study details as provided by Koning Corporation:

Primary Outcome Measures:
  • The study's intent is to provide compelling data to illustrate the potential contribution of CBCT for breast imaging, not to generate statistically significant data. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 104
Study Start Date: June 2008
Study Completion Date: May 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I Radiation: Computed Tomography
In Group I, twelve CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.
Experimental: Group II Radiation: Computed Tomography
In Group II , at least fifty (50) study participants, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a breast CBCT specifically designed to image the breast.
Experimental: Group III Radiation: Computed Tomography
In Group III, at least 30 study subjects, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a unilateral intravenous (IV) CE CBCT of the involved breast.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Group I:

  • Are at least 40 years of age of any ethnicity
  • Had a mammogram, read as BI-RADS® 1 or 2
  • Will undergo study imaging no later than four weeks from date of mammogram.
  • Is able to undergo informed consent.

Group II:

  • Are at least 40 years of age of any ethnicity
  • Had a routine mammogram, read as BI-RADS® 4 or 5
  • Are scheduled for breast biopsy
  • Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.
  • Is able to undergo informed consent.

Group III:

  • Are at least 40 years of age of any ethnicity
  • Had a routine mammogram, read as BI-RADS® 4 or 5
  • Are scheduled for breast biopsy
  • Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.
  • Is able to undergo informed consent.

Exclusion Criteria:

Group I and Group II:

  • Pregnancy
  • Lactation
  • Subjects 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.
  • Subjects who are unable to tolerate study constraints.
  • Subjects 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 Hodgkins disease
  • Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
  • Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

    • Tuberculosis
    • Severe scoliosis

Group III:

  • Pregnancy
  • Lactation
  • Subjects 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.
  • Subjects who are unable to tolerate study constraints.
  • Subjects 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 Hodgkins disease
  • Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
  • Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

    • Tuberculosis
    • Severe scoliosis
  • Allergy or previous reaction to iodinated contrast material
  • History of renal dysfunction/kidney disease
  • Long standing diabetes mellitus
  • Multiple myeloma
  • Dehydration
  • History of nephrotoxic medication use
  • Hyperthyroidism
  • Diabetic patients on Metformin
  • Pheochromocytoma
  • Sickle Cell Disease
  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: NCT00972413

Locations
United States, New York
Elizabeth Wende Breast Care
Rochester, New York, United States, 14620
Sponsors and Collaborators
Koning Corporation
Investigators
Principal Investigator: Posy Seifert, D.O. Elizabeth Wende Breast Care, LLC
  More Information

No publications provided

Responsible Party: Koning Corporation
ClinicalTrials.gov Identifier: NCT00972413     History of Changes
Other Study ID Numbers: KBCT-001
Study First Received: September 3, 2009
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Koning Corporation:
breast cancer
cone beam computed tomography

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

ClinicalTrials.gov processed this record on August 26, 2014