Cone Beam Computed Tomography for Breast Imaging

Completed

• Conditions: Breast Cancer
• Interventions: Device: Computed Tomography

• Registration Number: NCT01107860
• Lead Sponsor: Koning Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-21
• Primary Completion: 2012-12
• Status Verified: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-14
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 401

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I	Computed Tomography	-
Group II	Computed Tomography	-

Primary Outcome Measures

Name	Time	Method
Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology	about 3 years	The primary measure of this study will include the following aspects.; * the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam; * patient's comfort during the CBCT exam vs the mammographic exam; * the concordance and discordance of CBCT breast imaging with standard mammography and other breast-imaging studies; * the concordance and discordance of CBCT breast imaging with histopathology; * number of participants with adverse events as a measure of safety

Trial Locations

Locations (1)

Elizabeth Wende Breast Care; 🇺🇸 Rochester, New York, United States