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Cone Beam Computed Tomography for Breast Imaging

NCT ID: NCT00972413

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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breast cancer cone beam computed tomography

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group I

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type RADIATION

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.

Group II

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type RADIATION

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.

Group III

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Koning Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Posy Seifert, D.O.

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Wende Breast Care, LLC

Locations

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Elizabeth Wende Breast Care

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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KBCT-001

Identifier Type: -

Identifier Source: org_study_id