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Cone Beam Computed Tomography for Breast Imaging (CBCTBI)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Computed Tomography
Computed Tomography
Sponsored by
Koning Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer, cone beam computed tomography

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Elizabeth Wende Breast Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group I

Group II

Group III

Arm Description

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2009
Last Updated
December 13, 2012
Sponsor
Koning Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00972413
Brief Title
Cone Beam Computed Tomography for Breast Imaging
Acronym
CBCTBI
Official Title
Cone Beam Computed Tomography for Breast Imaging and IV Contrast Enhanced Cone Beam Computed Tomography Breast Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koning Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, cone beam computed tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Title
Group II
Arm Type
Experimental
Arm Title
Group III
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Computed Tomography
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Computed Tomography
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Computed Tomography
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Posy Seifert, D.O.
Organizational Affiliation
Elizabeth Wende Breast Care, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elizabeth Wende Breast Care
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States

12. IPD Sharing Statement

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Cone Beam Computed Tomography for Breast Imaging

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