Cone Beam Computed Tomography for Breast Imaging (CBCTBI)

December 13, 2012 updated by: Koning Corporation

Cone Beam Computed Tomography for Breast Imaging and IV Contrast Enhanced Cone Beam Computed Tomography Breast Imaging

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 1

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, 14620
        • Elizabeth Wende Breast Care

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

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
EXPERIMENTAL: Group II
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.
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.
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.
EXPERIMENTAL: Group III
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Collaborators and Investigators

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

Sponsor

Koning Corporation

Investigators

  • Principal Investigator: Posy Seifert, D.O., Elizabeth Wende Breast Care, LLC

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

June 1, 2008

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

September 3, 2009

First Submitted That Met QC Criteria

September 4, 2009

First Posted (ESTIMATE)

September 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 13, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBCT-001

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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