Clinical trial NCT01107860: Cone Beam Computed Tomography for Breast Imaging
Official title: Cone Beam Computed Tomography for Breast Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Koning Corporation
Sponsor class: INDUSTRY
Collaborators: name: Elizabeth Wende Breast Care, LLC
name: National Cancer Institute (NCI)
First posted: 2010-04-21
Enrollment: 401
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be selected from the patient population at a community based clinic, Elizabeth Wende Breast Care, LLC, which is located in Rochester, NY. Group I will consist of subjects who have had mammograms read as BIRADS® 1 or 2. Group II will be subjects who have had a diagnostic mammogram read as BIRADS® 4 or 5 prior to breast biopsy.

Brief summary: The primary aim of this study is to continue the investigation of cone beam computed tomography (CBCT) for breast imaging already underway in the diagnostic setting by providing a compelling body of evidence incorporating non-contrast 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:

* Females at least 35 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:

* Females at least 35 years of age of any ethnicity
* Require diagnostic imaging
* Will undergo study imaging no later than four weeks from date of diagnostic mammogram
* 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

Primary outcomes:
measure: Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology
timeFrame: about 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: