Clinical trial NCT01880580: Cone Beam CT for Breast Imaging
Official title: Cone Beam CT for Breast Imaging: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Imaging
Breast Cancer
Lead sponsor: Koning Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of Rochester
First posted: 2013-06-19
Enrollment: 76
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In Group I, up to 100 women, at least 40 years of age, who have had a routine standard mammogram read as BI-RADS® 0, 1, 2, or 3 will also undergo 3D breast imaging using a cone beam CT scanner specifically designed to image the breast.

Group II includes forty (40) women, who have had abnormalities detected by physical exam or an imaging modality and are also scheduled for breast biopsy of the index lesion, will also undergo a CBCT of the breast(s), prior to biopsy.

Brief summary: The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary data for a future extensive clinical trials.


Eligibility criteria: Normal Group:

Inclusion Criteria:

* Are at least 40 years of age of any ethnicity
* Had a routine mammogram, read as BI-RADS® 0, 1, 2 or 3
* Will undergo study imaging no later than six months from date of routine mammogram.
* Is able to undergo informed consent.

Exclusion Criteria:

* Pregnancy
* Lactation
* Patients 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.
* Patients who are unable to tolerate study constraints.
* Patients 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 Hodgkin's disease
* Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

  * Tuberculosis
  * Severe scoliosis

Diagnostic Group:

Inclusion Criteria:

* Women who are at least 40 years of age of any ethnicity
* Have a palpable abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE) or have a non-palpable abnormality detected by an imaging modality
* After diagnostic work-up are categorized as BI-RADS® 4 or 5.
* Are scheduled for biopsy either by large gauge needle biopsy or excisional biopsy.
* Will undergo study imaging prior to biopsy and within four weeks of diagnostic work-up.

Exclusion Criteria:

* Pregnancy
* Lactation
* Patients who have already undergone biopsy for the index lesion
* Patients who are unable or unwilling to undergo biopsy for the lesion of concern
* Patients with physical limitations that may prohibit the patient from resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
* Patients who are unable to tolerate study constraints.
* Patients who have received radiation treatments to the thorax or breast area 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 Hodgkin's disease
* Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Patients 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: Image Quality of Cone Beam Breast CT
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Highland Breast Imaging Center
state: New York
Study officials:
References:
citation: O'Connell A, Conover DL, Zhang Y, Seifert P, Logan-Young W, Lin CF, Sahler L, Ning R. Cone-beam CT for breast imaging: Radiation dose, breast coverage, and image quality. AJR Am J Roentgenol. 2010 Aug;195(2):496-509. doi: 10.2214/AJR.08.1017.
citation: O'Connell AM, Kawakyu-O'Connor D. Dedicated Cone-beam Breast Computed Tomography and Diagnostic Mammography: Comparison of Radiation Dose, Patient Comfort, And Qualitative Review of Imaging Findings in BI-RADS 4 and 5 Lesions. J Clin Imaging Sci. 2012;2:7. doi: 10.4103/2156-7514.93274. Epub 2012 Feb 25.