Cone Beam CT for Breast Imaging

Breast Cancer Clinical Trial

Official title:

Cone Beam CT for Breast Imaging: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880580
• Other study ID #: URMC-001
• Status: Completed
• Phase: N/A
• First received: June 15, 2013
• Last updated: June 18, 2013
• Start date: July 2006
• Est. completion date: June 2012

Study information

• Verified date: June 2013
• Source: Koning Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Imaging

Locations

Country	Name	City	State
United States	University of Rochester Highland Breast Imaging Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Koning Corporation	University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image Quality of Cone Beam Breast CT	This study was to evaluate the radiation dose, breast coverage, and image quality of cone-beam breast CT compared with a conventional mammographic examination.	6 years	Yes