Cone Beam CT for Breast Imaging

Completed

• Conditions: Breast Imaging; Breast Cancer

• Registration Number: NCT01880580
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-06
• Study First Submitted: 2013-06-15
• Study First Submitted QC: 2013-06-18
• Last Update Submitted: 2013-06-18
• Study First Posted: 2013-06-19
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Image Quality of Cone Beam Breast CT	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.

Trial Locations

Locations (1)

University of Rochester Highland Breast Imaging Center; 🇺🇸 Rochester, New York, United States