Clinical trial NCT00972413: Cone Beam Computed Tomography for Breast Imaging
Official title: Cone Beam Computed Tomography for Breast Imaging and IV Contrast Enhanced Cone Beam Computed Tomography Breast Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: breast cancer
cone beam computed tomography
Lead sponsor: Koning Corporation
Sponsor class: INDUSTRY
First posted: 2009-09-07
Enrollment: 104
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
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.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Elizabeth Wende Breast Care
state: New York
Study officials:
affiliation: Elizabeth Wende Breast Care, LLC
name: Posy Seifert, D.O.
role: PRINCIPAL_INVESTIGATOR
References: