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CompletedNCT00972413CBCTBIUpdated Dec 17, 2012

Cone Beam Computed Tomography for Breast Imaging

A Phase 1 interventional study of Computed Tomography and Computed Tomography in Breast Cancer, sponsored by Koning Corporation. Completed at 1 site in United States. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-17.

Sponsored by Koning Corporation · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
104
Allocation
Non-randomized
Ages
40 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer
  • cone beam computed tomography
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 104 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Koning Corporation is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • Experimental
    Group I

    Radiation: Computed Tomography

  • Experimental
    Group II

    Radiation: Computed Tomography

  • Experimental
    Group III

    Radiation: Computed Tomography

Interventions

  • RadiationComputed Tomography

    In Group I, twelve CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.

  • RadiationComputed Tomography

    In Group II , at least fifty (50) study participants, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a breast CBCT specifically designed to image the breast.

  • RadiationComputed Tomography

    In Group III, at least 30 study subjects, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a unilateral intravenous (IV) CE CBCT of the involved breast.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

07

Study locations

1 site
  • Elizabeth Wende Breast Care
    Rochester, New York 14620, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00972413
Lead sponsor
Koning Corporation
Responsible party
Sponsor
First posted
Sep 7, 2009
Start date
Jun 2008
Primary completion
Jan 2010
Completion
May 2012
Last update
Dec 17, 2012

Study contacts

Posy Seifert, D.O.
principal investigator · Elizabeth Wende Breast Care, LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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