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Cone Beam CT for Breast Imaging

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ClinicalTrials.gov Identifier: NCT01880580
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : June 19, 2013
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Koning Corporation

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.

Condition or disease
Breast Imaging Breast Cancer

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Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cone Beam CT for Breast Imaging: A Pilot Study
Study Start Date : July 2006
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Group/Cohort
Normal Group
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. Of these 100, we hope to enroll at least 30 subjects with mammograms read as BI-RADS® 0 and at least 30 read as BI-RADS® 3. The BI-RADS® 0 category refers to patients for whom additional imaging is required after a screening mammogram provided incomplete diagnostic information.
Diagnostic Group
The goals of Group II will be to compare the CBCT study with standard imaging for the diagnosis of breast disease in palpable or non-palpable breast lesions (having a BI-RADS® score of 4 or 5). 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.



Primary Outcome Measures :
  1. Image Quality of Cone Beam Breast CT [ Time Frame: 6 years ]
    This study was to evaluate the radiation dose, breast coverage, and image quality of cone-beam breast CT compared with a conventional mammographic examination.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880580


Locations
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United States, New York
University of Rochester Highland Breast Imaging Center
Rochester, New York, United States, 14620
Sponsors and Collaborators
Koning Corporation
University of Rochester