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


Phase 1
40 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Posy Seifert, D.O.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Elizabeth Wende Breast Care, LLC

Authority:

United States: Food and Drug Administration

Study ID:

KBCT-001

NCT ID:

NCT00972413

Start Date:

June 2008

Completion Date:

May 2012

Related Keywords:

  • Breast Cancer
  • breast cancer
  • cone beam computed tomography
  • Breast Neoplasms

Name

Location

Elizabeth Wende Breast CareRochester, New York  14620